510(k) Report

Devices descending from K121002

11 later devices reach Etest Ceftaroline through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151873Etest Ceftaroline (0.002 - 32ug/ml)Biomerieux S.A.201510—
+2K180936ETEST Telavancin (TLA) (0.002-32 ug/mL)Biomerieux S.A.20185—
+2K170670Etest Ceftolozane/ Tazobactam (0.016-256 ug/ml)bioMerieux, Inc.201731
+3K200512ETEST Plazomicin (PLZ) (0.016-256 µg/mL)Biomérieux SA20200—
+3K192738ETEST Delafloxacin (DFX) (0.002-32 µg/mL)Biomerieux S.A.20190—
+3K192050ETEST Eravacycline (ERV) (0.002 – 32 µg/mL)Biomerieux S.A.201921
+3K172150Etest Ceftazidime/Avibactam (CZA) (0.016 - 256 ug/mL)bioMerieux, Inc.201721
+4K250856ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL)Biomérieux20250—
+4K210757ETEST Fosfomycin (FO) (0.032-512 µg/mL)Biomerieux S.A.20211—
+4K190154ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL)Biomerieux S.A.20190—
+5K260447ETEST Gepotidacin (GEP) (0.016-256 µg/mL)bioMérieux SA20260—