Biomerieux S.A. is one of 174 FDA 510(k) medical device manufacturers from France in the dataset, ranked by real submission volume.
Biomerieux S.A. - FDA 510(k) Cleared Devices
Recent clearances: ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL), ETEST Fosfomycin (FO) (0.032-512 µg/mL), ETEST Delafloxacin (DFX) (0.002-32 µg/mL)
16
Total
16
Cleared
0
Denied
Biomerieux S.A. has 16 FDA 510(k) cleared microbiology devices. Based in Craponne, FR.
Latest FDA clearance: Apr 2025. Active since 2011.
Browse the complete list of FDA 510(k) cleared microbiology devices from this manufacturer. 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 S.A.
16 devices
Cleared
Apr 30, 2025
ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL)
Microbiology
90d
Cleared
Nov 12, 2021
ETEST Fosfomycin (FO) (0.032-512 µg/mL)
Microbiology
242d
Cleared
Nov 26, 2019
ETEST Delafloxacin (DFX) (0.002-32 µg/mL)
Microbiology
60d
Cleared
Sep 27, 2019
ETEST Eravacycline (ERV) (0.002 – 32 µg/mL)
Microbiology
58d
Cleared
Aug 22, 2019
ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL)
Microbiology
31d
Cleared
May 01, 2019
ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL)
Microbiology
91d
Cleared
Jan 11, 2019
ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/mL)
Microbiology
71d
Cleared
Jul 06, 2018
CHROMID CARBA agar (CARB)
Microbiology
72d
Cleared
Jul 03, 2018
ETEST Telavancin (TLA) (0.002-32 ug/mL)
Microbiology
84d
Cleared
Apr 27, 2017
RAPIDEC CARBA NP
Microbiology
245d
Cleared
Oct 07, 2015
Etest Ceftaroline (0.002 - 32ug/ml)
Microbiology
90d
Cleared
Jun 08, 2015
VIDAS FT4
Chemistry
705d