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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 10 of 87 Results
ProductCode: LON Applicant: BIOMERIEUX, INC. Decision Date To: 09/26/2022
 
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vitek 2 ast-yeast caspofungin (<=0.125 - >=8 µg/ml), vitek 2 ast-ys caspofungin (<=0.125 - >=8 µg/ml), vitek 2 ast-ys caspofungin bioMerieux, Inc. K213899 07/12/2022
vitek 2 ast-gram negative omadacycline (<=0.25 - >=16 µg/ml) bioMerieux, Inc. K213931 06/03/2022
vitek 2 ast-yeast fluconazole (<=0.5->=64 µg/ml), vitek 2 ast-ys fluconazole (<=0.5->=64 µg/ml), vitek 2 ast-ys fluconazole BioMerieux, Inc. K213241 02/25/2022
vitek 2 ast-gram positive fosfomycin (<=8 - >=256 ug/ml) bioMerieux, Inc. K202396 09/14/2021
vitek 2 ast-gram negative meropenem (<= 0.25 - >=16 µg/ml) bioMerieux, Inc. K201675 07/09/2021
vitek 2 ast-gram negative ceftazidime (=<0.5 - =>32 µg/ml) BioMerieux, Inc. K193299 09/28/2020
vitek 2 ast-gram negative imipenem/relebactam (<=0.25/4 - >=16/4 µg/ml) BioMerieux, Inc. K193572 03/13/2020
vitek 2 ast- gram negative polymyxin b (<=0.25 – >=16 ug/ml) BioMerieux, Inc. K193567 02/14/2020
vitek 2 ast-gram negative eravacycline (<=0.12 - >=4µg/ml) bioMerieux, Inc. K191766 08/05/2019
vitek 2 ast-gram positive dalbavancin (<= 0.015 - >= 1 µg/ml) bioMerieux, Inc. K190616 06/06/2019
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