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U.S. Department of Health and Human Services

510(k) Premarket Notification
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11 to 20 of 87 Results
ProductCode: LON Applicant: BIOMERIEUX, INC. Decision Date To: 03/24/2023
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Export all 87 Records to ExcelExport to Excel | Download Files | More About 510(k)
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vitek2 ast-gram negative delafloxacin (<=0.06->=4 ug/ml) bioMerieux, Inc. K183524 03/12/2019
vitek 2 ast-gram negative minocycline (<= 0.5 - >= 32 ug/ml) bioMerieux, Inc. K183551 03/07/2019
vitek 2 ast-gram negative imipenem (= 16 ug/ml) bioMerieux, Inc. K183415 02/20/2019
vitek 2 ast-gn ceftazidime/avibactam <=0.12 – >=16 µg/ml bioMerieux, Inc. K172944 12/19/2017
vitek 2 ast-gn amikacin (<=1 ->=64 ug/ml) bioMerieux, Inc. K172731 12/08/2017
vitek 2 ast gram negative cefotaxime (<=0.25 - >=64 ug/ml) BIOMERIEUX, INC. K161437 02/16/2017
vitek 2 ast-gn tobramycin (/= 16 ug/ml); vitek 2 ast-gram negative tobramycin (/=16 ug/ml) bioMerieux, Inc. K163083 02/01/2017
vitek 2 ast-gn tigecycline (<0.5->8 ug/ml) bioMerieux, Inc. K163006 01/24/2017
vitek 2 gram negative ceftriaxone (<=0.25->=64 ug/ml) bioMerieux, Inc. K161217 01/12/2017
vitek 2 ast gp ceftaroline BIOMERIEUX, INC. K141149 06/20/2014
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