Thermo Fisher Scientific Oy
VANTAA Uusimaa, FI
THERMO FISHER SCIENTIFIC OY appears in FDA device records in VANTAA Uusimaa, FI. FDA records list 65 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 5 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
Showing 50 of 65FDA records hold 65 510(k) clearances for Thermo Fisher Scientific Oy between 2007 and 2025. The busiest year on record is 2025, with 10. The most recent is 2025, with 10.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2007 | 2 |
| 2008 | 3 |
| 2009 | 4 |
| 2010 | 1 |
| 2013 | 1 |
| 2014 | 6 |
| 2015 | 7 |
| 2017 | 4 |
| 2018 | 2 |
| 2019 | 6 |
| 2020 | 2 |
| 2021 | 3 |
| 2023 | 8 |
| 2024 | 6 |
| 2025 | 10 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K252062 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mL | JWY | Substantially Equivalent | |
| K250575 | The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution range of 0.008/4 - 64/4 ug/mL | JWY | Substantially Equivalent | |
| K252014 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of 0.25-256 ug/mL | JWY | Substantially Equivalent | |
| K250990 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin in the dilution range of 0.002-64 ug/mL | JWY | Substantially Equivalent | |
| K242843 | The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL. | JWY | Substantially Equivalent | |
| K242659 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Vancomycin in the dilution range of 0.25-128 ug/mL | JWY | Substantially Equivalent | |
| K242658 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Moxifloxacin in the dilution range of 0.008-16 ug/mL | JWY | Substantially Equivalent | |
| K243738 | The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 µg/mL | NGZ | Substantially Equivalent | |
| K243201 | The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with penicillin in the dilution range of 0.015-32 ug/mL | JWY | Substantially Equivalent | |
| K242905 | The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Linezolid in the dilution range of 0.12-32 ug/mL | JWY | Substantially Equivalent | |
| K243169 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL | JWY | Substantially Equivalent | |
| K242653 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Linezolid in the dilution range of 0.25-32 ug/mL | JWY | Substantially Equivalent | |
| K242657 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Daptomycin in the dilution range of 0.03-64 ug/mL | JWY | Substantially Equivalent | |
| K242021 | The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Meropenem in the dilution range of 0.015 - 32 ug/ml. | JWY | Substantially Equivalent | |
| K241967 | The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with ceftriaxone in the dilution range of 0.015 - 2 ug/ml. | JWY | Substantially Equivalent | |
| K240445 | The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Imipenem in the dilution range of 0.015 - 4 ug/ml. | JWY | Substantially Equivalent | |
| K232310 | Sensititre 20-24 hour Haemophilus influenzaelStreptococcus pneumoniae MIC or Breakpoint Susceptibility System with Ceftolozane-tazobactam in the dilution range of 0.03/4-64/4ug/ml | JWY | Substantially Equivalent | |
| K231433 | The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mL | NGZ | Substantially Equivalent | |
| K231988 | Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dalbavancin in the dilution range of 0.0005-2µg/ml | JWY | Substantially Equivalent | |
| K231994 | Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Sulbactam-durlobactam in the dilution range of 0.015/4-32/4 ug/mL | JWY | Substantially Equivalent | |
| K230935 | Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC, or Breakpoint Susceptibility System with Imipenem-relebactam in the dilution, range of 0.03/4-128-4ug/ml (Haemophilus influenzae) | JWY | Substantially Equivalent | |
| K223844 | Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.00025-8ug/ml (Streptococcus species) and 0.000125-8ug/ml (Haemophilus influenzae) | JWY | Substantially Equivalent | |
| K221198 | Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range of 0.12-128ug/mL | NGZ | Substantially Equivalent | |
| K221899 | The Sensititre YeastOne Susceptibility System with Caspofungin in the dilution range of 0.015-16ug/ml | NGZ | Substantially Equivalent | |
| K203741 | Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 ug/ml | JWY | Substantially Equivalent | |
| K211539 | Sensititre YeastOne Susceptibility System with Voriconazole in the dilution range of 0.008 - 8 ug/mL | NGZ | Substantially Equivalent | |
| K202612 | Sensititre 20-24 hour Haemophilus influenzae /Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dtest (containing erythromycin at 1 ug/mL and clindamycin at 0.5 ug/mL) | JWY | Substantially Equivalent | |
| K193538 | Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 µg/ml | JWY | Substantially Equivalent | |
| K193024 | Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint, Susceptibility System with Lefamulin in the dilution range of 0.008-16ug/mL | JWY | Substantially Equivalent | |
| K192729 | Sensititre 18-24 Hour MIC or Breakpoint Susceptibility System with Lefamulin in the dilution range of 0.008-16ug/ml | JWY | Substantially Equivalent | |
| K191918 | Thermo Scientific Sensititre ARIS HiQ System | LRG | Substantially Equivalent | |
| K191914 | Thermo Scientific Sensititre ARIS HiQ System | LRG | Substantially Equivalent | |
| K192250 | Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Imipenem-Relebactam in the dilution range of 0.03/4-256/4 ug/mL | JWY | Substantially Equivalent | |
| K183324 | Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.008 - 32 ug/mL | JWY | Substantially Equivalent | |
| K183033 | Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.03-32ug/ml | JWY | Substantially Equivalent | |
| K182797 | Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Eravacycline in the dilution range of 0.008- 16 µg/mL | JWY | Substantially Equivalent | |
| K181946 | Sensititre 18-24 hour MIC Breakpoint Susceptibility System with Plazomicin in the dilution range of 0.06-128 ug/mL | JWY | Substantially Equivalent | |
| K173209 | Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Meropenem/Vaborbactam in the Dilution Range of 0.008/8 - 18/8 ug/mL | JWY | Substantially Equivalent | |
| K172454 | Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.004-8 ug/mL | JWY | Substantially Equivalent | |
| K172274 | The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.00025-8µg/mL | JWY | Substantially Equivalent | |
| K171870 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.0005 – 8 ug/mL | JWY | Substantially Equivalent | |
| K152774 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftazidime/Avibactam in the dilutions range of 0.015/4 - 32/4 ug/mL | JWY | Substantially Equivalent | |
| K150556 | Sensititre 18-24 hours MIC or BP Susceptibility System with Ceftolozane/tazobactam (0.03/4- 64/4ug/mL) | JWY | Substantially Equivalent | |
| K150236 | Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Dalbavancin (0.0005 - 2ug/mL) | JWY | Substantially Equivalent | |
| K143288 | Sensititre Susceptibility plates | JWY | Substantially Equivalent | |
| K143526 | The Sensititre HP MIC Susceptibility plate with Oritavancin (0.0005-8mcg/ml) | JWY | Substantially Equivalent | |
| K142338 | Sensititre HP MIC Susceptibility Plate with Tedizolid (0.002-4 mcg/ml) | JWY | Substantially Equivalent | |
| K143381 | Sensititre Susceptibility Plates | JWY | Substantially Equivalent | |
| K142151 | SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES | JWY | Substantially Equivalent | |
| K141651 | SENSITITRE SUSCEPTIBILITY PLATES | JWY | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9610942 | 3007262384 | THERMO FISHER SCIENTIFIC OY | 2 RATASTIE, VANTAA Uusimaa 01620 FI | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use
- DLJCalibrators, Drug Specific
- JFJCatalytic Methods, Amylase
- JSOCulture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
- JRICuvette, Thermostated
- JCBDetergent
- PSZDevices Detecting Influenza A, B, And C Virus Antigens
- DIFDrug Mixture Control Materials
- CGZElectrode, Ion-Specific, Chloride
- KLREnzyme Immunoassay, Lidocaine
- DJREnzyme Immunoassay, Methadone
- LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
- CFRHexokinase, Glucose
- LRGInstrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
- JWYManual Antimicrobial Susceptibility Test Systems
- OAVMycophenolic Acid Test System
- NGZSusceptibility Test Plate, Antifungal
- DHBSystem, Test, Radioallergosorbent (Rast) Immunological
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1202-2021 | Cascadion SM Clinical Analyzer, REF 99990000 SN Type: 9910 | Due to software defect, under certain assay parameters, false Vitamin D results may be reported. The system reports a false result by not quantitating the correct analyte peak in sample chromatogram. The resulting sample would show a Vitamin D-concentration that is an unusual situation for human serum and plasma samples and would indicate a severe Vitamin D deficiency. | Class II | Terminated | |
| Z-1735-2011 | Thermo Scientific HM 560 Cold Disinfection Cryostat, Microm International GmbH, Waldorf, Germany Tissue processing equipment used to prepare human tissue specimens for diagnostic histological examination by processing specimens through the various stages of decalcifying, infiltrating, sectioning, and mounting on microscope slides. | Through internal quality review, firm determined the need to conduct a more comprehensive system validation to support the claim of complete bacterial, fungal and viral disinfection efficacy. | Terminated | ||
| Z-1734-2011 | Thermo Scientific HM 550 Cold Disinfection Cryostat, Microm International GmbH, Waldorf, Germany Tissue processing equipment used to prepare human tissue specimens for diagnostic histological examination by processing specimens through the various stages of decalcifying, infiltrating, sectioning, and mounting on microscope slides. | Through internal quality review, firm determined the need to conduct a more comprehensive system validation to support the claim of complete bacterial, fungal and viral disinfection efficacy. | Terminated | ||
| Z-1320-2010 | ThermoFisher Scientific Microm STP 420D automated tissue processor. | The firm has received complaints regarding specimen integrity (higher rate of specimen fragmentation) as well as complaints that the chamber may stop rotating prematurely, resulting in sample deterioration. | Terminated | ||
| Z-0015-2008 | Ammonia Liquid Stable Reagent, Enzymatic Method. Catalog number TR60101. in vitro diagnostic. | Method is susceptible to positive interference from endogenous ALT in patient samples. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain