510(k) Report

Devices descending from K972265

15 later devices reach A1C 2.2 Plus - Automated Glycohemoglobin Analyzer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K041764The Vitros 5,1 FS Chemistry SystemOrtho-Clinical Diagnostics20044—
+1K011434G7 Automated HPLC AnalyzerTosoh Medics, Inc.2001112
+2K142595VITROS Chemistry Products HbA 1c Reagent Kit, VITROS Calibrator Kit 31, VITROS Chemistry…Ortho Clinical Diagnostics201502
+2K100304ST Aia Pack HBA1CTosoh Bioscience, Inc.201004
+2K081895Advia Chemistry Hemoglobin A1C, Advia Chemistry A1C CalibratorsSiemens Medical Solutions Diagnostics200912
+2K071132G8 Automated HPLC Analyzer, Model HLC-723 G8Tosoh Bioscience, Inc.200841
+2K072686Axsym HBA1C Reagents, Axsym HBA1C Calibrators, Axsym HBA1C ControlsAxis-Shield Diagnostics, Ltd.20081—
+2K060650Vitros Chemistry Products D%A1C Reagent Kit, Model 680 2314; Vitros Chemistry Products…Ortho-Clinical Diagnostics, Inc.20060—
+2K033674Multigent Hemoglobin A1C (Reagents), HB A1C Calibrators and HB A1C ControlsSeradyn, Inc.20040—
+3K162822ADAMS A1c HA-8180V, CALIBRATOR 80Arkray Factory, Inc.20170—
+3K121842Architect HBA1C, Architect HBA1C, and Architect HBA1CAxis-Shield Diagnostics, Ltd.201201
+3K122101Capillarys Hemoglobin HBA1C Capillarys 2 Flex Piercing Capillarys HBA1C Controls…Sebia20122—
+3K110934Advia Chemistry Hemoglobin A1C_3 (A1C_3) Automated Pretreatment AssaySiemens Healthcare Diagnostics201102
+4K162281CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2)Sebia20170—
+4K133344Minicap HB A1C, Minicap Flex-Piercing, HB A1C Capillarys Controls, HBA1C Capillarys…Sebia20141—