510(k) Report

Devices descending from K103798

2 later devices reach BD Probetec Herpes Simplex Viruses (HSV 1& 2) Q Amplified Dna Assays through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162673Aptima Herpes Simplex Viruses 1 & 2 AssayHologic, Inc.20170—
+1K150617cobas HSV 1 and 2 TestRoche Molecular Systems, Inc.20150—