510(k) Report

Devices descending from K922201

5 later devices reach Coamate Protein C Chromogenic Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K050365Biophen Protein C5, C2.5, Models 221205, 221202Hyphen Biomed200501
+1K023990Chromocheck Protein C 25; Chromocheck Protein C 50Precision Biologic20031—
+1K980875IL Test Protein CInstrumentation Laboratory CO19981—
+2K062430Hemosil Protein CInstrumentation Laboratory CO20060—
+2K050448Chromopep PC, Chromopep at, Models 2.5 and 5Horiba Abx20050—