Thermofisher Scientific Oy
Vantaa, FI
Thermofisher Scientific OY appears in FDA device records in Vantaa, FI. FDA records list 8 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show one recall for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 8 510(k) clearances for Thermofisher Scientific Oy between 2007 and 2011. The busiest year on record is 2008, with 4. The most recent is 2011, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2007 | 3 |
| 2008 | 4 |
| 2011 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K110035 | INDIKO | JJE | Substantially Equivalent | |
| K073295 | UREA/BUN, SCAL, NORTROL, ABTROL | CDQ | Substantially Equivalent | |
| K073612 | URIC ACID (AOX), SCAL, NORTROL, ABTROL | JIX | Substantially Equivalent | |
| K073355 | CALCIUM, SCAL, NORTROL, ABTROL | CJY | Substantially Equivalent | |
| K073191 | ALKALINE PHOSPHATASE (IFCC) PLUS, ECAL, NORTROL, ABTROL | CJE | Substantially Equivalent | |
| K070824 | CREATININE (ENZYMATIC) | JFY | Substantially Equivalent | |
| K071340 | CARBON DIOXIDE (CO2), SCAL, NORTROL AND ABTROL | KHS | Substantially Equivalent | |
| K071580 | AST/GOT (IFCC), PYRIDOXAL PHOSPHATE, ECAL, NORTROL AND ABTROL | CIT | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use
- CJYAzo Dye, Calcium
- JIXCalibrator, Multi-Analyte Mixture
- JFYEnzymatic Method, Creatinine
- KHSEnzymatic, Carbon-Dioxide
- CITNadh Oxidation/Nad Reduction, Ast/Sgot
- CJENitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
- CDQUrease And Glutamic Dehydrogenase, Urea Nitrogen
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2159-2008 | 10% Buffered Formalin Phosphate; Certified For laboratory and manufacturing use only, not for drug, food or household use. Do not Transfer to an unmarked container. Catalog numbers: SF100-4, SF100-20 Fisher Scientific, Fail Lawn, NJ 07410 | Assay tests on retention sample of 10% Buffered Formalin Phosphate showed it to be 3.417%, which is below the specification of 4-5%. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain