510(k) Report

Devices descending from K052464

3 later devices reach Tina-Quant Hemoglobin A1C Gen.2 Test through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K072714Tina-Quant Hemoglobin A1C Gen.2 Test SystemRoche Diagnostics Corp.200821
+2K110313Tina-Quant HBA1C Gen.2Roche Diagnostics20110—
+2K102914TQ HBA1C GEN3Roche20110—