BIOMERIEUX is one of 271 FDA 510(k) medical device manufacturers from France in the dataset, ranked by real submission volume.
BIOMERIEUX - FDA 510(k) Cleared Devices
Recent clearances: VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL), VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M, VIDAS Human Chorionic Gonadotropin, VIDAS T4, VIDAS Testosterone, VIDAS TSH, and VIDAS D-Dimer Exclusion II, ETEST TOBRAMYCIN 0.016-256 UG/ML AND 0.064-1024 UG/ML
3
Total
3
Cleared
0
Denied
BIOMERIEUX has 3 FDA 510(k) cleared medical devices. Based in Craponne, FR.
Latest FDA clearance: Mar 2026. Active since 2010. Primary specialty: Microbiology.
Browse the FDA 510(k) cleared devices submitted by BIOMERIEUX Filter by specialty or product code using the sidebar.
1 submission has an FDA-authorized Predetermined Change Control Plan (PCCP), indicating AI or software-based device development.
FDA 510(k) Regulatory Record - BIOMERIEUX
3 devices
Cleared
Mar 26, 2026
VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL)
Microbiology
56d
Cleared
Jul 09, 2015
VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M,...
Microbiology
434d
Cleared
Nov 17, 2010
ETEST TOBRAMYCIN 0.016-256 UG/ML AND 0.064-1024 UG/ML
Microbiology
62d