510(k) Report

Devices descending from K051231

2 later devices reach Verifynow-P2Y12 Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141427Accumetrics,Inc. Verifynow Prutest, Accumetrics, Inc. Verifynow PrutestAccumetrics, Inc.201512
+2K181777AggreGuide A-100 ADPAggredyne, Inc.201901