510(k) Report

Devices descending from K102668

12 later devices reach Etest Tobramycin 0.016-256 UG/ML and 0.064-1024 UG/ML through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121002Etest CeftarolinebioMerieux, Inc.2012115
+2K151873Etest Ceftaroline (0.002 - 32ug/ml)Biomerieux S.A.201510—
+3K180936ETEST Telavancin (TLA) (0.002-32 ug/mL)Biomerieux S.A.20185—
+3K170670Etest Ceftolozane/ Tazobactam (0.016-256 ug/ml)bioMerieux, Inc.201731
+4K200512ETEST Plazomicin (PLZ) (0.016-256 µg/mL)Biomérieux SA20200—
+4K192738ETEST Delafloxacin (DFX) (0.002-32 µg/mL)Biomerieux S.A.20190—
+4K192050ETEST Eravacycline (ERV) (0.002 – 32 µg/mL)Biomerieux S.A.201921
+4K172150Etest Ceftazidime/Avibactam (CZA) (0.016 - 256 ug/mL)bioMerieux, Inc.201721
+5K250856ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL)Biomérieux20250—
+5K210757ETEST Fosfomycin (FO) (0.032-512 µg/mL)Biomerieux S.A.20211—
+5K190154ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL)Biomerieux S.A.20190—
+6K260447ETEST Gepotidacin (GEP) (0.016-256 µg/mL)bioMérieux SA20260—