# Brahms GmbH

- Location (FDA's records): Henningsdorf, DE
- FDA decisions: 2 (2016–2017): 1 510(k) clearance and 1 De Novo grant
- Product codes: PRI (1), PMT (1)
- Predicates its devices cite: 2 (1 its own); citations of its devices by later devices: 11 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- bioMerieux, Inc.: 1 (https://510kreport.com/company/biomerieux)

## Firms that cite its devices most
- Siemens Healthcare Diagnostics, Inc.: 3 (https://510kreport.com/company/siemens-healthcare-diagnostics)
- Roche Diagnostics Corp.: 2 (https://510kreport.com/company/roche-diagnostics)
- bioMerieux, Inc.: 1 (https://510kreport.com/company/biomerieux)
- Ortho-Clinical Diagnostics, Inc.: 1 (https://510kreport.com/company/ortho-clinical-diagnostics)
- Fujirebio Diagnostics,Inc.: 1 (https://510kreport.com/company/fujirebio-diagnostics)
- Immunexpress, Inc.: 1 (https://510kreport.com/company/immunexpress)
- Fisher Diagnostics: 1 (https://510kreport.com/company/fisher-diagnostics)

## Its most-cited devices
- K171338: B R A H M S PCT sensitive KRYPTOR (2017), cited by 6
- DEN150009: B.R.A.H.M.S PCT sensitive KRYPTOR (2016), cited by 5

## Recent decisions
- K171338: B R A H M S PCT sensitive KRYPTOR (May 31, 2017)
- DEN150009: B.R.A.H.M.S PCT sensitive KRYPTOR (Feb 20, 2016)

Source page: https://510kreport.com/company/brahms