Thermo Electron Oy
Louisville, CO, US
Thermo Electron OY appears in FDA device records in Louisville, CO. FDA records list 14 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 14
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 14 510(k) clearances for Thermo Electron Oy between 2004 and 2007. The busiest year on record is 2007, with 10. The most recent is 2007, with 10.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2004 | 1 |
| 2005 | 2 |
| 2006 | 1 |
| 2007 | 10 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K063145 | PHENOBARBITAL, PHENYTOIN, TDM CALIBRATION SET B AND ABTROL/NORTROL CONTROLS | DIP | Substantially Equivalent | |
| K063705 | LITHIUM MICRO VOLUME ELECTRODE, THEOPHYLLINE, ISE CALIBRATORS 1, 2 AND 3, TDM CALIBRATION SET B, NORTROL AND ABTROL | NDW | Substantially Equivalent | |
| K063131 | CARBAMAZEPINE, VALPROIC ACID, TDM CALIBRATION SET B AND ABTROL, NORTROL CONTROLS | KLT | Substantially Equivalent | |
| K063838 | LIPOPROTEIN(A), LIPOPROTEIN(A) CALIBRATOR, LIPOPROTEIN (A) CONTROL, CONTROL HIGH | DFC | Substantially Equivalent | |
| K063086 | TRANSFERRIN, SPECICAL CALIBRATOR, SPECITROL AND SPECITROL HIGH CONTROLS | DDG | Substantially Equivalent | |
| K061412 | THERMO ELECTRON ENZYMATIC CREATININE, MODEL TR35401 | JFY | Substantially Equivalent | |
| K063209 | HBA1C; CALIBRATOR; CONTROL NORMAL, CONTROL ABNORMAL | LCP | Substantially Equivalent | |
| K063150 | COMPLEMENT C3 AND C4, SPECICAL CALIBRATOR AND SPECITROL CONTROL AND HIGH CONTROL | CZW | Substantially Equivalent | |
| K062521 | OXALATE URINE CONTROLS (NORMAL AND ELEVATED) | JIT | Substantially Equivalent | |
| K063647 | CYSTATIN C ANTISERUM, CALIBRATOR, CONTROL AND CONTROL HIGH | NDY | Substantially Equivalent | |
| K061107 | DPC T60I KUSTI, MODEL 984248; DPC T60I, MODEL 984247 | CEM | Substantially Equivalent | |
| K052056 | DATA-TROL N NORMAL CONTROL SERUM, DATA-TROL A ABNORMAL CONTROL SERUM | JJY | Substantially Equivalent | |
| K042767 | DATAPRO CLINICAL CHELISTRY ANALYZER | CFR | Substantially Equivalent | |
| K041657 | THERMO ELECTRON ANGIOTENSIN CONVERTING ENZYME INFINITY (ACE) REAGENT | KQN | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- LCPAssay, Glycosylated Hemoglobin
- NDWAssay, Porphyrin, Spectrophotometry, Lithium
- JITCalibrator, Secondary
- CZWComplement C3, Antigen, Antiserum, Control
- CEMElectrode, Ion Specific, Potassium
- JFYEnzymatic Method, Creatinine
- KLTEnzyme Immunoassay, Carbamazepine
- DIPEnzyme Immunoassay, Diphenylhydantoin
- CFRHexokinase, Glucose
- DFCLipoprotein, Low-Density, Antigen, Antiserum, Control
- JJYMulti-Analyte Controls, All Kinds (Assayed)
- KQNRadioassay, Angiotensin Converting Enzyme
- NDYTest, Cystatin C
- DDGTransferrin, Antigen, Antiserum, Control
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain