510(k) Report

Devices descending from K003619

5 later devices reach Dried Gram-Positive Mic/Combo Panels through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K131275Microscan Dried Gram-Postive Mic/Combo PanelsSiemens Helathcare Diagnostics, Inc.20130—
+1K123933Microscan Dried Gram-Positive Mic/Combo Panels - CeftarolineSiemens Healthcare Diagnostics, Inc.20133—
+2K150039MicroScan Dried Gram Positive MIC/Combo Panels with vancomycin (0.25-64 mcg/mL)Siemens Healthcare Diagnostics, Inc.20152—
+3K250036MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL)Beckman Coulter, Inc.20250—
+3K152346MicroScan Dried Gram Positive MIC/Combo Panels - Vancomycin (0.25-64 ug/mL)Beckman Coulter, Inc.20150—