Biomerieux S.A. - FDA 510(k) Cleared Devices
16
Total
16
Cleared
0
Denied
FDA 510(k) cleared devices by Biomerieux S.A. Microbiology ✕
15 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
Oct 09, 2013
VIDAS C DIFFICILE GDH
Microbiology
100d
Cleared
Jun 04, 2013
VIDAS LYME IGM
Microbiology
251d
Cleared
Mar 05, 2013
VIDAS LYME IGG
Microbiology
160d
Cleared
May 16, 2011
ETEST TELAVANCIN IN 0.002-32 UG/ML AND 0.016-256 UG/ML
Microbiology
255d