510(k) Report

Devices descending from K180936

5 later devices reach ETEST Telavancin (TLA) (0.002-32 ug/mL) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200512ETEST Plazomicin (PLZ) (0.016-256 µg/mL)Biomérieux SA20200—
+1K192738ETEST Delafloxacin (DFX) (0.002-32 µg/mL)Biomerieux S.A.20190—
+1K192050ETEST Eravacycline (ERV) (0.002 – 32 µg/mL)Biomerieux S.A.201921
+2K210757ETEST Fosfomycin (FO) (0.032-512 µg/mL)Biomerieux S.A.20211—
+3K260447ETEST Gepotidacin (GEP) (0.016-256 µg/mL)bioMérieux SA20260—