510(k) Report

Devices descending from K040872

3 later devices reach Variant II Hemoglobin A1C through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K070819Variant II Turbo Link Hemoglobin A1C Program, and Variant II Turbo Link Hemoglobin…Bio-Rad Laboratories Inc., Clinical Systems Divisi200715
+1K063400Variant II Turbo Hemoglobin A1C Program, Hemoglobin Testing System with CDM 4.0Bio-Rad Laboratories, Inc.200624
+2K140801Variant II Turbo Link Hemoglobin A1C Program/Testing SystemBio-Rad Laboratories, Inc.20140—