510(k) Report

Devices descending from K963111

5 later devices reach Coatest Apc (TM) Resistance V/Coatest Apc (TM) Resistance V S through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K260551HemosIL Factor V Leiden (APC Resistance V)Instrumentation Laboratory (IL) Co.20260—
+1K083729Hemoclot Quanti- V-L, Factor V-L Calibrator, Biophen V-L Cal (Undiluted), Biophen Act.…Aniara Diagnostica, LLC20090—
+1K042760Pefakit Apc-R Factor V Leiden ControlsPentapharm, Ltd.20040—
+1K042762Pefakit Apc-R Factor V LeidenPentapharm, Ltd.20040—
+1K042333Control Plasma N, Proc Control PlasmaDade Behring, Inc.20040—