Thermofisher Scientific OY: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Thermofisher Scientific OY” (first 2007, latest 2011), across 8 product codes in 1 review panel. Median 510(k) review time under this name: 149 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Thermo Fisher Scientific, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 1 | 1 |
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 1 | 1 |
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | 1 | 1 |
| CJY | Azo Dye, Calcium | 1 | 1 |
| JFY | Enzymatic Method, Creatinine | 1 | 1 |
| JIX | Calibrator, Multi-Analyte Mixture | 1 | 1 |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 | 1 |
| KHS | Enzymatic, Carbon-Dioxide | 1 | 1 |
Review panels
Most recent Thermofisher Scientific OY 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K110035 | INDIKO | JJE | 2011-06-28 | 174 |
| K073295 | UREA/BUN, SCAL, NORTROL, ABTROL | CDQ | 2008-05-29 | 188 |
| K073612 | URIC ACID (AOX), SCAL, NORTROL, ABTROL | JIX | 2008-05-23 | 154 |
| K073355 | CALCIUM, SCAL, NORTROL, ABTROL | CJY | 2008-02-28 | 91 |
| K073191 | ALKALINE PHOSPHATASE (IFCC) PLUS, ECAL, NORTROL, ABTROL | CJE | 2008-02-28 | 107 |
| K070824 | CREATININE (ENZYMATIC) | JFY | 2007-12-03 | 252 |
| K071340 | CARBON DIOXIDE (CO2), SCAL, NORTROL AND ABTROL | KHS | 2007-10-05 | 144 |
| K071580 | AST/GOT (IFCC), PYRIDOXAL PHOSPHATE, ECAL, NORTROL AND ABTROL | CIT | 2007-10-03 | 117 |
Recalls
openFDA lists no recalls under a recalling firm named Thermofisher Scientific OY.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Thermofisher Scientific OY?
FDA lists 8 510(k) clearances under the applicant name “Thermofisher Scientific OY” (first 2007, latest 2011), across 8 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Thermofisher Scientific OY?
The median time from FDA receipt to decision across 510(k)s cleared under the name Thermofisher Scientific OY is 149 days.
Which FDA product codes appear under Thermofisher Scientific OY?
The most frequent FDA product codes under this applicant name are CDQ (Urease And Glutamic Dehydrogenase, Urea Nitrogen, 1); CIT (Nadh Oxidation/Nad Reduction, Ast/Sgot, 1); CJE (Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes, 1).
Next steps
- See all 8 Thermofisher Scientific OY clearances with predicates and recalls
- Run predicate analysis for product code CDQ, Thermofisher Scientific OY's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.