ClearanceBrief
Panels › Hematology › Product code LCP · Class 2

Assay, Glycosylated Hemoglobin

Regulation 864.7470

0510(k)s in 12 months (249 all time)
1recalls in 12 months (103 all time)
98recalls that name a 510(k)
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Top companies in LCP

Company510(k)sRecalls
Heritage Labs International LLC037
Bio-Rad Laboratories, Inc.828
Helena Laboratories190
Bio-Rad150
Siemens Healthcare Diagnostics312
Primus Corp.90
Metrika, Inc.71
Roche Diagnostics53
Abbott Laboratories70
Isolab, Inc.70
Decided510(k)Device and applicantCode
Nov 22, 2024K221326Nova Allegro HbA1c Assay, Nova Allegro Analyzer
Nova Biomedical Corporation
LCP
Dec 6, 2023K231465Q-Pad Test System
Qurasense
LCP
Sep 27, 2023K214117Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 Analyzer
Abbott Diagnostics Technologies AS, NO
LCP
Mar 26, 2020K192987Aina HbA1c Monitoring System 2
Jana Care, Inc.
LCP
Oct 29, 2019K192369PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit
Ixensor Co, Ltd., TW
LCP
Aug 15, 2019K183230OneDraw A1C Test System
Drawbridge Health, Inc.
LCP
Apr 12, 2019K181915PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit
Ixensor Co, Ltd., TW
LCP
Feb 16, 2019K180509Quo-Test A1c System
Ekf-Diagnostic GmbH, DE
LCP
Sep 25, 2018K173127skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c Reagent Kit)
Skyla Corporation H.S.P.B, TW
LCP
Feb 27, 2018K170623ACE Hemoglobin A1c (HbA1c) Reagent
Alfa Wassermann Diagnostic Technologies, LLC
LCP
Nov 21, 2017K171650Alere Afinion HbA1c and ACR on Afinion 2 analyzer
Abbott Rapid Diagnostics
LCP
Oct 12, 2017K170147Lucica Glycated Albumin-L
Asahi Kasei Pharma Corporation, JP
LCP
Jul 28, 2017K163633cobas HbA1c Test, cobas b 101 system
Roche Diagnostics Operations
LCP
Jun 16, 2017K161533A1C EZ Glycohemoglobin Analysis System
Biohermes Co., Ltd., CN
LCP
Feb 17, 2017K162281CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2)
Sebia
LCP
Nov 21, 2016K160762Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c
Diazyme Laboratories
LCP
Jan 29, 2016K142664URight Hemoglobin A1c system, FORA A1c System
Taidoc Technology Corporation, TW
LCP
Sep 30, 2015K140827SD A1cCare System, SD A1cCare Spoit Type Test Kit, SD HbA1c Control Set
Sd Biosensor, Inc., KR
LCP
Sep 25, 2015K151809Alere Afinion HbA1c, Alere Afinion AS100 Analyzer
Alere Technologies AS, NO
LCP
Mar 13, 2015K141944HOME ACCESS AIC TEST
Home Access Health Corp.
LCP
Dec 16, 2014K142789A1c iGear System
Sakae Corporation, JP
LCP
Aug 6, 2014K133803DIAZYME GLYCATED SERUM PROTEIN POC TEST KIT
Diazyme Laboratories
LCP
Jul 24, 2014K141750HEMOCUE HBA1C 501 GLYCOSYLATED HEMOGLOBIN MONITORING SYSTEM
Infopia Co, Ltd.
LCP
Jul 14, 2014K140829UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN A1C3 (HBA1C3) REAGENT
Beckman Coulter, Inc.
LCP
Jun 25, 2014K140801VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM/TESTING SYSTEM
Bio-Rad Laboratories, Inc.
LCP
Apr 4, 2014K130014A1C GEAR SYSTEM
Sakae Corporation
LCP
Mar 28, 2014K133344MINICAP HB A1C, MINICAP FLEX-PIERCING, HB A1C CAPILLARYS CONTROLS, HBA1C CAPILLARYS CALIBRATORS
Sebia
LCP
Jan 24, 2014K131307ADVIA CHEMISTRY FRUCTOSAMINE ASSAY, ADVIA CHEMISTRY FRUCTOSAMINE CALIBRATOR
Siemens Healthcare Diagnostics, Inc.
LCP
May 9, 2013K130990VARIANT(TM) II TURBO HBA1C KIT - 2.0
Bio-Rad Laboratories, Inc., Clinical Systems Divis
LCP
Apr 25, 2013K130860VARIANT II HEMOGLOBIN A1C PROGRAM (NEW), VARIANT II HEMOGLOBIN TESTING SYSTEM WITH CDM SOFTWARE, CDM SOFTWARE
Bio-Rad Laboratories, Inc., Clinical Systems Divis
LCP
Dec 12, 2012K121842ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT HBA1C
Axis-Shield Diagnostics, Ltd., GB
LCP
Dec 6, 2012K122101CAPILLARYS HEMOGLOBIN HBA1C CAPILLARYS 2 FLEX PIERCING CAPILLARYS HBA1C CONTROLS CAPILLARYS HBA1C C
Sebia
LCP
Oct 26, 2012K122472VARIANT II TURBO HBA1C KIT-2.0 VARIANT II TURBO HEMOGLOBIN TESTING SYSTEM
Bio-Rad Laboratories, Inc., Clinical Systems Divis
LCP
Oct 12, 2012K120199GLYCOSYLATED HEMOGLOBIN ASSAY; CLINICAL CHEMISTRY
Beckman Coulter, Inc.
LCP
Sep 13, 2012K111128LABONACHECK A1C
Ceragem International, Inc.
LCP
Sep 11, 2012K121492UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN ALC-(HBA1C-) REAGENT
Beckman Coulter, Inc.
LCP
Sep 7, 2012K121366HEMOCUE HBA1C 501
Infopia Co, Ltd.
LCP
Aug 6, 2012K113437ACE HEMOGLOBIN ALC(HBALC) REAGENT, ACE CEDIA T UPTAKE REAGENT, ACE T4 REAGENT, ACE FERRITIN REAGENT
Alfa Wassermann Diagnostic Technologies, Inc.
LCP
May 14, 2012K120497EASYRA HBALC REGENT EASYCAL HBLC CALIBRATOR EASYQC HBALC MATERIAL
Medica Corp.
LCP
Dec 23, 2011K110313TINA-QUANT HBA1C GEN.2
Roche Diagnostics
LCP
Nov 22, 2011K112015PREMIER HB9210 HBA1C ANALYZER
Primus Corporation Dba Trinity Biotech
LCP
Aug 25, 2011K110934ADVIA CHEMISTRY HEMOGLOBIN A1C_3 (A1C_3) AUTOMATED PRETREATMENT ASSAY
Siemens Healthcare Diagnostics
LCP
Jul 20, 2011K093548AVIE A1C TEST SYSTEM
Mec Dynamics Corp
LCP
May 19, 2011K100547ELITECH CLINICAL SYSTEMS HBA1C REAGENT, ELITECH CLINCAL SYSTEM HBA1C CALIBRATOR SET, ELITECH CLINICAL
Seppim S.A.S.
LCP
May 17, 2011K110188DIAZYME GLYCATED SERUM PROTEIN ASSAY / CALIBRATOR KIT / CONTROL KIT
Diazyme Laboratories
LCP
May 13, 2011K102510DIMENSIONS HB1C KIT, MODEL DF105A
Siemens Healthcare Diagnostics
LCP
Feb 15, 2011K110056AFINION ANALYZER
Axis-Shield Poc AS, NO
LCP
Feb 14, 2011K102045DIMENSION VISA HBA1C, MODEL K3105A
Siemens Heatlhcare Diagnostics, Inc.
LCP
Jan 20, 2011K102914TQ HBA1C GEN3
Roche
LCP
Aug 27, 2010K100304ST AIA PACK HBA1C
Tosoh Bioscience, Inc.
LCP

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