Thermo Electron OY: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Thermo Electron OY” (first 2006, latest 2007), across 9 product codes in 4 review panels. Median 510(k) review time under this name: 275 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 |
|---|---|---|---|
| CEM | Electrode, Ion Specific, Potassium | 1 | 1 |
| CZW | Complement C3, Antigen, Antiserum, Control | 1 | 1 |
| DDG | Transferrin, Antigen, Antiserum, Control | 1 | 1 |
| DFC | Lipoprotein, Low-Density, Antigen, Antiserum, Control | 1 | 1 |
| DIP | Enzyme Immunoassay, Diphenylhydantoin | 1 | 1 |
| KLT | Enzyme Immunoassay, Carbamazepine | 1 | 1 |
| LCP | Assay, Glycosylated Hemoglobin | 1 | 1 |
| NDW | Assay, Porphyrin, Spectrophotometry, Lithium | 1 | 1 |
| NDY | Test, Cystatin C | 1 | 1 |
Review panels
- Immunology (3)
- Clinical Toxicology (3)
- Clinical Chemistry (2)
- Hematology (1)
Most recent Thermo Electron OY 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K063145 | PHENOBARBITAL, PHENYTOIN, TDM CALIBRATION SET B AND ABTROL/NORTROL CONTROLS | DIP | 2007-10-17 | 366 |
| K063705 | LITHIUM MICRO VOLUME ELECTRODE, THEOPHYLLINE, ISE CALIBRATORS 1, 2 AND 3, TDM CALIBRATION SET B, NORTROL AND ABTROL | NDW | 2007-10-09 | 300 |
| K063131 | CARBAMAZEPINE, VALPROIC ACID, TDM CALIBRATION SET B AND ABTROL, NORTROL CONTROLS | KLT | 2007-10-05 | 357 |
| K063838 | LIPOPROTEIN(A), LIPOPROTEIN(A) CALIBRATOR, LIPOPROTEIN (A) CONTROL, CONTROL HIGH | DFC | 2007-09-27 | 275 |
| K063086 | TRANSFERRIN, SPECICAL CALIBRATOR, SPECITROL AND SPECITROL HIGH CONTROLS | DDG | 2007-08-08 | 302 |
| K063209 | HBA1C; CALIBRATOR; CONTROL NORMAL, CONTROL ABNORMAL | LCP | 2007-03-21 | 149 |
| K063150 | COMPLEMENT C3 AND C4, SPECICAL CALIBRATOR AND SPECITROL CONTROL AND HIGH CONTROL | CZW | 2007-03-19 | 154 |
| K063647 | CYSTATIN C ANTISERUM, CALIBRATOR, CONTROL AND CONTROL HIGH | NDY | 2007-03-12 | 95 |
| K061107 | DPC T60I KUSTI, MODEL 984248; DPC T60I, MODEL 984247 | CEM | 2006-08-08 | 110 |
Recalls
openFDA lists no recalls under a recalling firm named Thermo Electron 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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Thermo Fisher Scientific (65 510(k)s)
- Thermo Biostar, Inc. (5 510(k)s)
- Thermo-Electron Corp. (5 510(k)s)
- Thermo Dma, Inc. (4 510(k)s)
- Thermo Temp, Inc. (4 510(k)s)
- Thermo Fisher Scientific (Oxoid Ltd.) (3 510(k)s)
- Thermo Orion (3 510(k)s)
- Thermo Bioanalysis Corp. (2 510(k)s)
- Thermo Body Wrap Systems, Inc. (1 510(k)s)
- Thermo-Electric Co. (1 510(k)s)
- Thermo Fisher Scientific (Life Technologies Holdin (1 510(k)s)
- Thermo Fisher Scientific (Nalge Nunc Intl) (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Thermo Electron OY?
FDA lists 9 510(k) clearances under the applicant name “Thermo Electron OY” (first 2006, latest 2007), across 9 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Thermo Electron OY?
The median time from FDA receipt to decision across 510(k)s cleared under the name Thermo Electron OY is 275 days.
Which FDA product codes appear under Thermo Electron OY?
The most frequent FDA product codes under this applicant name are CEM (Electrode, Ion Specific, Potassium, 1); CZW (Complement C3, Antigen, Antiserum, Control, 1); DDG (Transferrin, Antigen, Antiserum, Control, 1).
Next steps
- See all 9 Thermo Electron OY clearances with predicates and recalls
- Run predicate analysis for product code CEM, Thermo Electron 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.