510(k) Report

Devices descending from DEN130049

2 later devices reach Simplexa HSV 1&2 Direct through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250050miDiagnostics HSV-1&2 CSF TestMidiagnostics NV20250—
+1K141458Simplexa HSV 1&2 Direct/Positive Control PackFocus Diagnostics20140Class I