510(k) Report

Devices descending from K183031

3 later devices reach ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/mL) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250274ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL)Biomerieux S.A.20250—
+1K232395ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUDBiomérieux20230—
+1K191953ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL)Biomerieux S.A.201902