510(k) Report

Devices descending from K954105

2 later devices reach Eia Kit for the Detction of Anti-PR3 Antibodies through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K973822Virgo Anca Screen KitHemagen Diagnostics, Inc.19970—
+1K973823PR 3 Antibody KitHemagen Diagnostics, Inc.19970—