510(k) Report

Devices descending from K213931

2 later devices reach VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 µg/mL) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222073VITEK 2 AST-Gram Negative Cefazolin (<=1 - >=32 ug/mL)bioMerieux, Inc.20231—
+2K251579VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)bioMerieux, Inc.20250—