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Biomerieux S.A.

FDA 510(k) & PMA Approved Devices — 14 products

Total Devices14
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K250274 ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL)JWY2025-04-30 View
510(k) K210757 ETEST Fosfomycin (FO) (0.032-512 µg/mL)JWY2021-11-12 View
510(k) K192738 ETEST Delafloxacin (DFX) (0.002-32 µg/mL)JWY2019-11-26 View
510(k) K192050 ETEST Eravacycline (ERV) (0.002 – 32 µg/mL)JWY2019-09-27 View
510(k) K191953 ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL)JWY2019-08-22 View
510(k) K190154 ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL)JWY2019-05-01 View
510(k) K183031 ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/mL)JWY2019-01-11 View
510(k) K181092 CHROMID CARBA agar (CARB)JSO2018-07-06 View
510(k) K180936 ETEST Telavancin (TLA) (0.002-32 ug/mL)JWY2018-07-03 View
510(k) K162385 RAPIDEC CARBA NPPTJ2017-04-27 View
510(k) K132010 VIDAS C DIFFICILE GDHMCB2013-10-09 View
510(k) K122979 VIDAS LYME IGMLSR2013-06-04 View
510(k) K122986 VIDAS LYME IGGLSR2013-03-05 View
510(k) K102535 ETEST TELAVANCIN IN 0.002-32 UG/ML AND 0.016-256 UG/MLJWY2011-05-16 View
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