510(k) Report

Devices descending from K964151

3 later devices reach Bard and Bta Test through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K994356ImmunocytDiagnocure, Inc.20000—
+1K974845Bta Stat Test Prescription Home UseBard Diagnostic Sciences,Inc.19980—
+1K971402Bard Bta Trak TestBard Diagnostic Sciences,Inc.19980—