Thermo Biostar, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Thermo Biostar, Inc.” (first 2002, latest 2004), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 154 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 |
|---|---|---|---|
| GOG | Antisera, Cf, Poliovirus 1-3 | 1 | 1 |
| GQG | Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus | 1 | 1 |
| LIR | Antigen, Enzyme Linked Immunoabsorbent Assay, Neisseria Gonorrhoeae | 1 | 1 |
| LJC | Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group) | 1 | 1 |
| PSZ | Devices Detecting Influenza A, B, And C Virus Antigens | 1 | 1 |
Review panels
- Microbiology (5)
Most recent Thermo Biostar, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K032330 | CT OIA | LJC | 2004-03-02 | 217 |
| K023947 | GC OIA | LIR | 2003-04-17 | 141 |
| K023556 | FLU OIA A/B TEST KIT | PSZ | 2003-03-27 | 155 |
| K023779 | RSV OIA | GQG | 2003-01-14 | 63 |
| K021172 | RSV OIA | GOG | 2002-09-13 | 154 |
Recalls
openFDA lists no recalls under a recalling firm named Thermo Biostar, Inc..
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Thermo Biostar, Inc. (a text match, not an official crosswalk):
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 Electron OY (9 510(k)s)
- Thermo Dma, Inc. (4 510(k)s)
- Thermo Temp, Inc. (4 510(k)s)
- Thermo Electron Corporation (3 510(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 Fisher Scientific (Life Technologies Holdin (1 510(k)s)
- Thermo Fisher Scientific (Nalge Nunc Intl) (1 510(k)s)
- Thermo Forma, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Thermo Biostar, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Thermo Biostar, Inc.” (first 2002, latest 2004), across 5 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 Thermo Biostar, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Thermo Biostar, Inc. is 154 days.
Which FDA product codes appear under Thermo Biostar, Inc.?
The most frequent FDA product codes under this applicant name are GOG (Antisera, Cf, Poliovirus 1-3, 1); GQG (Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus, 1); LIR (Antigen, Enzyme Linked Immunoabsorbent Assay, Neisseria Gonorrhoeae, 1).
Next steps
- See all 5 Thermo Biostar, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GOG, Thermo Biostar, Inc.'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.