Brahms Diagnostica, LLC: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Brahms Diagnostica, LLC” (first 1999, latest 2004), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 85 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 |
|---|---|---|---|
| JZO | System, Test, Thyroid Autoantibody | 5 | 5 |
| MSW | System, Test, Thyroglobulin | 1 | 1 |
Review panels
- Immunology (6)
Most recent Brahms Diagnostica, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K033454 | BRAHMS DIAGNOSTICA LUMITEST TRAK HUMAN | JZO | 2004-03-22 | 144 |
| K021057 | BRAHMS DIAGNOSTICA DYNOTEST TG-PLUS | MSW | 2002-09-17 | 169 |
| K000287 | BRAHMS DIAGNOSTICA LUMITEST ANTI-TPO | JZO | 2000-03-17 | 46 |
| K000286 | BRAHMS DIAGNOSTICA LUMITEST ANTI-TG | JZO | 2000-03-17 | 46 |
| K992791 | BRAHMS DIAGNOSTICA DYNOTEST ANTI-TPO | JZO | 1999-11-12 | 85 |
| K992790 | BRAHMS DIAGNOSTICA DYNOTEST ANTI-TG | JZO | 1999-11-12 | 85 |
Recalls
openFDA lists no recalls under a recalling firm named Brahms Diagnostica, LLC.
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.
- Brahms Aktiengesellschaft (2 510(k)s)
- Brahms GmbH (1 510(k)s)
- Brahms GmbH, Part of Thermo Fisher Scientific (0 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Brahms Diagnostica, LLC?
FDA lists 6 510(k) clearances under the applicant name “Brahms Diagnostica, LLC” (first 1999, latest 2004), across 2 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 Brahms Diagnostica, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Brahms Diagnostica, LLC is 85 days.
Which FDA product codes appear under Brahms Diagnostica, LLC?
The most frequent FDA product codes under this applicant name are JZO (System, Test, Thyroid Autoantibody, 5); MSW (System, Test, Thyroglobulin, 1).
Next steps
- See all 6 Brahms Diagnostica, LLC clearances with predicates and recalls
- Run predicate analysis for product code JZO, Brahms Diagnostica, LLC'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.