510(k) Report

Devices descending from K934070

17 later devices reach Tina-Quant Hemoglobin A1C through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K052464Tina-Quant Hemoglobin A1C Gen.2 TestRoche Diagnostics Corp.20053—
+1K052101C.F.a.S. (Calibrator for Automated Systems) HBA1CRoche Diagnostics20056—
+1K031604GlycomarkTomen America, Inc.20031—
+1K982022Vigil Hemoglobin (Hbalc) ControlsBeckman Coulter, Inc.19980—
+1K974491Accu-Chek A1C Hemoglobin TestBoehringer Mannheim Corp.19981—
+1K973696Synchron System Hemoglobin Alc ReagentBeckman Instruments, Inc.199702
+2K180209Diazyme 1,5-AG AssayDiazyme Laboratories, Inc.20180—
+2K142595VITROS Chemistry Products HbA 1c Reagent Kit, VITROS Calibrator Kit 31, VITROS Chemistry…Ortho Clinical Diagnostics201502
+2K130255Hemoglobin A1C, Hemoglobin A1C Calibrators, Hemoglobin A1C ControlsAbbott Laboratories201443
+2K072714Tina-Quant Hemoglobin A1C Gen.2 Test SystemRoche Diagnostics Corp.200821
+2K983253Precision A1C Home HBA1C Sample Collection KitMedisense, Inc.19980—
+3K173206SEKURE HbA1c AssaySekisui Diagnostics P.E.I., Inc.20180—
+3K171771ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) AssaySiemens Healthcare Diagnostics, Inc.201711
+3K140654Hemoglobin A1c Assay, Hemoglobin A1c Calibrators, Hemoglobin A1c ControlsAbbott Laboratories201502
+3K110313Tina-Quant HBA1C Gen.2Roche Diagnostics20110—
+3K102914TQ HBA1C GEN3Roche20110—
+4K200256ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) AssaySiemens Healthcare Diagnostics, Inc.202102