510(k) Report

Devices descending from K150039

2 later devices reach MicroScan Dried Gram Positive MIC/Combo Panels with vancomycin (0.25-64 mcg/mL) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250036MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL)Beckman Coulter, Inc.20250—
+1K152346MicroScan Dried Gram Positive MIC/Combo Panels - Vancomycin (0.25-64 ug/mL)Beckman Coulter, Inc.20150—