510(k) Report

Devices descending from K191766

7 later devices reach VITEK 2 AST-Gram Negative Eravacycline (<=0.12 - >=4µg/mL) through their predicates, nearest generation first.

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