510(k) Report

Devices descending from K021022

2 later devices reach Hemosil Low Abnormal Controlled (Assayed); Hemosil Low Abnormal Control 2… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082859Hemosil Routine Control Level 1, Level 2, Level 3 UnassayedInstrumentation Laboratory CO20081—
+2K110432Visucon-F Frozen Coag Screen N, Visucon-F Frozen Coag Screen AbnAffinity Biologicals, Inc.20110—