510(k) Report

Devices descending from K192050

2 later devices reach ETEST Eravacycline (ERV) (0.002 – 32 µg/mL) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K210757ETEST Fosfomycin (FO) (0.032-512 µg/mL)Biomerieux S.A.20211—
+2K260447ETEST Gepotidacin (GEP) (0.016-256 µg/mL)bioMérieux SA20260—