510(k) Report

Devices descending from K003280

2 later devices reach Variant II Total GHB through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K063643Modification to Variant II: Hemoglobin A1C Program, Beta-Thalassemia Short Program and…Bio-Rad Laboratories Inc., Clinical Systems Divisi200611
+2K130860Variant II Hemoglobin A1C Program (New), Variant II Hemoglobin Testing System with CDM…Bio-Rad Laboratories, Inc., Clinical Systems Divis20130—