510(k) Report

Devices descending from K151906

1 later device reach ARIES HSV 1&2 Assay Cassettes - Carton of 24 (IVD), ARIES HSV 1&2 Assay… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180559HSV 1 & 2 ELITe MGB Kit; ELITe InGeniusElitechgroup20180—