510(k) Report

Devices descending from K931117

4 later devices reach Assess (TM) Low Abnormal Control through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K022046Vital Scientific Coagulation Control,Coagulation Control Level 1,2,3,Quikcoag…Vital Scientific N.V.20020—
+1K021022Hemosil Low Abnormal Controlled (Assayed); Hemosil Low Abnormal Control 2 (Unassayed)Instrumentation Laboratory CO200223
+2K082859Hemosil Routine Control Level 1, Level 2, Level 3 UnassayedInstrumentation Laboratory CO20081—
+3K110432Visucon-F Frozen Coag Screen N, Visucon-F Frozen Coag Screen AbnAffinity Biologicals, Inc.20110—