510(k) Report

Devices descending from K183524

9 later devices reach VITEK2 AST-Gram Negative Delafloxacin (<=0.06->=4 ug/mL) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K193567VITEK 2 AST- Gram Negative Polymyxin B (<=0.25 – >=16 ug/mL)bioMerieux, Inc.202001
+1K191766VITEK 2 AST-Gram Negative Eravacycline (<=0.12 - >=4µg/mL)bioMerieux, Inc.20197—
+2K222430VITEK 2 AST-Gram Negative Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin (<=4…Biomerieux Sa, Inc.20230—
+2K213931VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 µg/mL)bioMerieux, Inc.20222—
+2K214023VITEK 2 AST-Gram Negative Ciprofloxacin (?0.06 - ?4 µg/mL)bioMerieux, Inc.20220—
+2K201675VITEK 2 AST-Gram Negative Meropenem (<= 0.25 - >=16 µg/mL)bioMerieux, Inc.20210—
+2K193299VITEK 2 AST-Gram Negative Ceftazidime (=<0.5 - =>32 µg/mL)bioMerieux, Inc.20200—
+3K222073VITEK 2 AST-Gram Negative Cefazolin (<=1 - >=32 ug/mL)bioMerieux, Inc.20231—
+4K251579VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)bioMerieux, Inc.20250—