FDA 510(k) Applications Submitted by BIOMERIEUX SA

FDA 510(k) Number	Submission Date	Device Name	Applicant
K180936	04/10/2018	ETEST Telavancin (TLA) (0.002-32 ug/mL)	bioMerieux SA
K181092	04/25/2018	CHROMID CARBA agar (CARB)	bioMerieux SA
K162385	08/25/2016	RAPIDEC CARBA NP	BIOMERIEUX SA
K102535	09/03/2010	ETEST TELAVANCIN IN 0.002-32 UG/ML AND 0.016-256 UG/ML	BIOMERIEUX SA
K132058	07/03/2013	VIDAS FT4	BIOMERIEUX SA
K132010	07/01/2013	VIDAS C DIFFICILE GDH	BIOMERIEUX SA
K122979	09/26/2012	VIDAS LYME IGM	BIOMERIEUX SA
K122986	09/26/2012	VIDAS LYME IGG	BIOMERIEUX SA
K151873	07/09/2015	Etest Ceftaroline (0.002 - 32ug/ml)	BIOMERIEUX SA
K190154	01/30/2019	ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL)	bioMerieux SA
K210757	03/15/2021	ETEST Fosfomycin (FO) (0.032-512 ╡g/mL)	bioMerieux SA
K191953	07/22/2019	ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL)	BioMerieux SA
K192050	07/31/2019	ETEST Eravacycline (ERV) (0.002 û 32 ╡g/mL)	bioMerieux SA
K183031	11/01/2018	ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 ╡g/mL)	bioMerieux SA
K192738	09/27/2019	ETEST Delafloxacin (DFX) (0.002-32 ╡g/mL)	BioMerieux SA