510(k) Report

Devices descending from K153687

3 later devices reach Liofilchem MIC Test Strip (MTS)-Vancomycin 0.016 -256 ug/mL through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K260696MTS Gepotidacin 0.016-256 µg/mLLiofilchem s.r.l.20260—
+1K252114MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mLLiofilchem s.r.l.20250—
+1K251580MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD)Liofilchem s.r.l.20250—