# bioMerieux, Inc.

- Location (FDA's records): Hazelwood, MO
- FDA decisions: 283 (1983–2026): 279 510(k) clearances, 1 De Novo grant and 3 original PMA approvals
- Names in FDA's records: bioMerieux, Inc. (256); Biomerieux S.A. (16); BIOMERIEUX (3); Biomérieux (2); Biomérieux, Inc. (2); Biomérieux SA (2); Biomerieux Sa, Inc. (1); bioMérieux SA (1)
- Product codes: LON (118), JSJ (18), JWY (18), JSG (13), MDB (12), JSH (12), JSI (11), NGZ (10), JSF (7), JSO (5), DAP (4), KZI (3)
- 510(k) review time since 2016: median 90 days, against 90 for FDA's reviews in the same codes and years (31 of 67 faster)
- Predicates its devices cite: 176 (135 its own); citations of its devices by later devices: 165 (135 its own)
- Recalls linked to its devices: 163 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Organon Teknika Corp.: 10 (https://510kreport.com/company/organon-teknika)
- Biomerieux Vitek, Inc.: 5 (https://510kreport.com/company/biomerieux-vitek)
- Tosoh Medics, Inc.: 3 (https://510kreport.com/company/tosoh-medics)
- Bio-Rad: 3 (https://510kreport.com/company/bio-rad)
- Vitek Systems, Inc.: 2 (https://510kreport.com/company/vitek-systems)
- Remel Co.: 2 (https://510kreport.com/company/remel)
- Banyan Biomarkers, Inc.: 1 (https://510kreport.com/company/banyan-biomarkers)
- Techlab, Inc.: 1 (https://510kreport.com/company/techlab)

## Firms that cite its devices most
- Quidel Corp.: 4 (https://510kreport.com/company/quidel)
- Instrumentation Laboratory CO: 3 (https://510kreport.com/company/instrumentation-laboratory)
- Roche Diagnostics Corp.: 2 (https://510kreport.com/company/roche-diagnostics)
- Bruker Daltonics, Inc.: 2 (https://510kreport.com/company/bruker-daltonics)
- Diagnostica Stago, Inc.: 2 (https://510kreport.com/company/diagnostica-stago)
- Siemens Healthcare Diagnostics, Inc.: 2 (https://510kreport.com/company/siemens-healthcare-diagnostics)
- Copan Wasp Srl: 2 (https://510kreport.com/company/copan-wasp)
- Abbott Laboratories: 2 (https://510kreport.com/company/abbott-laboratories)

## Its most-cited devices
- K063597: Vitek 2 Gram Positive Amoxicillin for Streptococcus Pneumoniae (2007), cited by 12
- K040882: Vidas D-Dimer Exclusion Assay, Model 30 442 (2004), cited by 9
- K121546: Vitek 2 Gram Negative Doxycycline (2012), cited by 7
- K162827: Vidas B.R.a.H.M.S. PCT (PCT) (2017), cited by 6
- K191766: VITEK 2 AST-Gram Negative Eravacycline (<=0.12 - >=4µg/mL) (2019), cited by 5
- K072038: Vitek 2 Gram Negative Levofloxacin (2007), cited by 4

## Recent decisions
- K260283: VITEK 2 AST-Streptococcus Meropenem (=0.06 - =4 µg/mL) (Oct 1, 2026)
- K260619: VITEK 2 AST-Streptococcus Cefepime (<=0.06 – >=4 µg/mL) (Sep 28, 2026)
- K260160: VITEK REVEAL GN AST Assay and VITEK REVEAL AST System (Jul 8, 2026)
- K260447: ETEST Gepotidacin (GEP) (0.016-256 µg/mL) (Apr 21, 2026)
- K260282: VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance (Apr 15, 2026)
- K260281: VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL) (Mar 26, 2026)
- K251579: VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL) (Aug 21, 2025)
- K250856: ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL) (Jun 12, 2025)

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