510(k) Report

Devices descending from K090699

2 later devices reach Variant II Turbo HBA1C Kit Kit-20 and Wash/Diluent Solution Set, Models… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122472Variant II Turbo HBA1C Kit-2.0 Variant II Turbo Hemoglobin Testing SystemBio-Rad Laboratories, Inc., Clinical Systems Divis20121—
+2K130990Variant (TM) II Turbo HBA1C Kit - 2.0Bio-Rad Laboratories, Inc., Clinical Systems Divis20130—