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

DateFirm and productCodeLinked 510(k)
Dec 1, 2025GET TESTED INTERNATIONAL AB
Diabetes HbA1c Test
Open, Classified
LCPNone listed
May 27, 2025Mckesson Medical-Surgical Inc. Corporate Office
ABBOTT RAPID DX N AMERICA LLC HBA1C HEMOGLOBIN AFINION GLYCTD (15TST/BX) TEST KIT.
Open, Classified
LCPK171650
Oct 24, 2024Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.
A1CNow+ Multi-Test HbA1c System consists of (1) a semi-disposable plastic-encased device (the monitor), (2) a plastic cartridge enclosing dry reagent strips, and (3) a sample dilution kit for: collect
Completed
LCPK090413
Aug 27, 2024Abbott Diagnostics Technologies AS
Afinion 2 Analyzer, model #1116986, US refurbished, CLIA waived.
Open, Classified
LCPK171650
Mar 19, 2024Siemens Healthcare Diagnostics, Inc.
DCA Systems HbA1c Reagent Kit
Open, Classified
LCPK951361
Feb 9, 2022Siemens Healthcare Diagnostics, Inc.
Atellica CH Fructosamine (Fruc), Siemens Material Number 11097637
Open, Classified
LCPK131307
Jun 30, 2020Siemens Healthcare Diagnostics, Inc.
DCA Vantage Handheld Barcode Scanner - Zebra Model - Model # DS4308 - HC0015BZZWW external accessory to DCA Vantage Analyzer US
Terminated
LCPK071466
Jun 5, 2020Siemens Healthcare Diagnostics, Inc.
Atellica CH Fructosamine Reagent (FRUC), Siemens Material Number 11097637, UDI Number 00630414595580 use in the quantitative measurement of glycated protein (fructosamine) in human serum and plasma fo
Terminated
LCPK131307
Jun 5, 2020Siemens Healthcare Diagnostics, Inc.
ADVIA Chemistry Fructosamine Reagent (FRUC), Siemens Material Number 10361941, UDI Number 00630414558073 - Product Usage: use in the quantitative measurement of glycated protein (fructosamine) in huma
Terminated
LCPK131307
Oct 5, 2018Tosoh Bioscience Inc
Hemoglobin A1c Control, Part no. 220232 for use as quality control material to monitor the precision of laboratory testing procedures for HbA1c quantitation.
Terminated
LCPK021484
Jul 13, 2018Tosoh Bioscience Inc
G8 Automated HPLC Analyzer - 723G8 Product Usage - In vitro diagnostic use for the quantitative measurement of % hemoglobin A1c in whole blood specimens. This test is to be used as an aid in the diag
Terminated
LCPK131580
Jun 6, 2018Tosoh Bioscience Inc
G8 Automated HPLC Analyzer: HLC-723G8-ST, 021560; and HLC-723G8-LA, 021674 Product Usage: The Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 is intended for in vitro diagnostic use for the quanti
Terminated
LCPK100304
Mar 5, 2018Tosoh Bioscience Inc
Tosoh ST AIA-PACK HbA1c, HbA1c Reagent, Pt. No. 025218 The device is designed for In Vitro Diagnostic Use Only for the quantitative measurement for percent concentration of Hemoglobin A1c (HbA1c) in
Terminated
LCPK100304
Jun 7, 2017Randox Laboratories Ltd.
Rx series HbA1c REF/Catalog Number HA3830, GTIN 05055273203561, IVD; -- RANDOX LABORATORIES LTD. , This product is suitable for use on RX series instruments which includes the RX Daytona and RX Imola
Terminated
LCPK021897
Dec 2, 2016Polymer Technology Systems
CVS Health At Home A1C Test Kit, Software Version Revision D, REF Number 3059
Terminated
LCPK090413
Dec 2, 2016Polymer Technology Systems
ReliOn FastA1C Test, Software Version Revision D, REF Number 3055
Terminated
LCPK090413
Dec 2, 2016Polymer Technology Systems
Walgreens At-Home A1C Test Kit, Software Version Revision D, REF Number 3056
Terminated
LCPK090413
Dec 2, 2016Polymer Technology Systems
A1CNow SELF CHECK (European), Software Version Revision D, REF Numbers 3054, 3062
Terminated
LCPK090413
Dec 2, 2016Polymer Technology Systems
A1CNow+ Systems (professional use product), Software Version Revision D, REF Numbers US: 3021, 3024; EU: 3037, 3038, 3057, 3058
Terminated
LCPK090413
Nov 11, 2016Roche Diagnostics Operations, Inc.
Tina-Quant Hemoglobin A1c Gen. 2 Hemoglobin A1c test Catalog number 04528123190 / 05401640190
Terminated
LCPK072714
Jul 20, 2016Siemens Healthcare Diagnostics, Inc.
ADVIA Chemistry XPT, SMN 10723034, IVD. --- This issue affects only the ADVIA Chemistry Hemoglobin A1c_3 Automated Pretreatment (A1c_3) results when HbA1c values are reported in International Federati
Terminated
LCPK110934
Jan 27, 2016Bio-Rad Laboratories, Inc.
D-10 Rack Loader; Model Number 220-0600; Hematology: The D-10 is a fully integrated system for sample dilution, processing and analysis of hemoglobin, designed for use with specific Bio-Rad reagent k
Terminated
LCPK060001
Nov 25, 2015Siemens Healthcare Diagnostics, Inc.
ADVIA Chemistry Hemoglobin A1c_3, A1c_3M Reagent kits. Used on the ADVIA 1200, 1650, 1800, 2400, and XPT Chemistry Systems. For in vitro diagnostic use in the quantitative determination of Hemoglobi
Terminated
LCPK110934
Jul 14, 2015Tosoh Bioscience, Inc.
G7 Variant Elution Buffer HiS no. 1 (M) component of the Tosoh Automated Glycohemoglobin Analyzer HLC 723G7. Product Usage: G7 Variant Elution Buffer HiS No 1. (M) is one of the buffers used on Toso
Terminated
LCPK011434
Nov 21, 2014Siemens Healthcare Diagnostics, Inc.
Siemens Dimension HB1C Flex reagent cartridge; Dimension Hemoglobin A1c (HB1C) Flex reagent cartridge on the Dimension clinical chemistry system is an in vitro diagnostic assay for the quantitative de
Terminated
LCPK102045
K102510
Oct 24, 2014Siemens Healthcare Diagnostics, Inc.
Dimension Vista HbA1c
Terminated
LCPK102045
Mar 27, 2014Bio-Rad Laboratories, Inc.
D-10" Hemoglobin Testing System, Model number: 220-0220 Manufactured by: Bio-Rad Laboratories, Inc. 4000 Alfred Nobel Drive Hercules, CA 94545 The D-10 Hemoglobin Testing System is a single module
Terminated
LCPK031043
Feb 10, 2014Bio-Rad Laboratories, Inc.
D-10 Dual Program, which contains Update Kit D-10 A1c program diskette. United States; Bio-Rad Laboratories, Hercules, CA 94547 The Bio-Rad D-10 Hemoglobin Testing System provides an integrated meth
Terminated
LCPK031043
Jan 3, 2014Siemens Healthcare Diagnostics, Inc.
HbA1c Flex(R) reagent cartridge (K3105A, Siemens Material Number 10470481) for the Dimension(R) Clinical Systems. Dimension(R) Hemoglobin A1c (HB1C) Flex(R) reagent Cartridge on the Dimension(R) clin
Terminated
LCPK102045
Jan 3, 2014Siemens Healthcare Diagnostics, Inc.
HB1C Flex(R) Reagent Cartridge (DF105A, Siemens Material Number 10483822) for the Dimension(R) Clinical Systems. Dimension(R) Hemoglobin A1c (HB1C) Flex(R) reagent Cartridge on the Dimension(R) clini
Terminated
LCPK011852
Nov 2, 2013Bayer Healthcare Llc
Bayer brand A1CNow+ MULTI-TEST A1C SYSTEM TEST KITS (PART NUMBER 3021/08842610); Hemoglobin A1c Monitor; Glycosylated Hemoglobin Assay; Product is manufactured and distributed by Bayer HealthCare LLC
Terminated
LCPK090413
Sep 3, 2013Siemens Healthcare Diagnostics
ADVIA Chemistry A1c_3 Calibrators, Catalog Number 10491408, IVD --- COMMON/USUAL NAME: ADVIA Chemistry A1c_3 Calibrators Shipping or unit package: Level 1: 2 x 0.5 g; Level 2: 2 x 0.5 g; Level 3: 2 x
Terminated
LCPK081895
Jan 11, 2012Heritage Labs International LLC
Principal Combo Test Pak, Product K8700, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, blood specimen collection supplies and
Terminated
LCPK990899
Jan 11, 2012Heritage Labs International LLC
Appraise DBS Test Pak/HW-Kronos KROJI, Product K8603, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, blood specimen collection
Terminated
LCPK990899
Jan 11, 2012Heritage Labs International LLC
Heritage Labs University of Michigan Clinical Kit, Product K8311, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, blood specime
Terminated
LCPK990899
Jan 11, 2012Heritage Labs International LLC
University of Mannheim DBS Collection Kit, Product K8308, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, blood specimen collec
Terminated
LCPK990899
Jan 11, 2012Heritage Labs International LLC
Principal Waist Circumference DBS Collection Kit, Product K8307, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, blood specimen
Terminated
LCPK990899
Jan 11, 2012Heritage Labs International LLC
University of Michigan DBS Collection Kit, Product K8306, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, blood specimen collect
Terminated
LCPK990899
Jan 11, 2012Heritage Labs International LLC
H & W Principal DBS Collection Kit, Product K8305, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, blood specimen collection sup
Terminated
LCPK990899
Jan 11, 2012Heritage Labs International LLC
Heritage Labs Appraise DBS Bio Disk Test, Product K8304-QNS, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, blood specimen coll
Terminated
LCPK990899
Jan 11, 2012Heritage Labs International LLC
HooperHolmes Health & Wellness, Product K8303, each kit packed in an envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, blood specimen collection supplies and
Terminated
LCPK990899
Jan 11, 2012Heritage Labs International LLC
Appraise DBS Kit, Product K8302, each kit packed in a bag or envelope. (This kit was previously Product A1773, which is listed separately due to the new part number.) Each kit contains 1 Triad Mediu
Terminated
LCPK990899
Jan 11, 2012Heritage Labs International LLC
Appraise DBS Test Pak/Moore Medical LLC, Product K8301, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, and blood specimen colle
Terminated
LCPK990899
Jan 11, 2012Heritage Labs International LLC
Appraise/Heritage Combo A1C & Blood Test Kit, Product K8300, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, and blood specimen
Terminated
LCPK990899
Jan 11, 2012Heritage Labs International LLC
Appraise/Heritage Combo Kit, Product K8100, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, and blood specimen collection suppli
Terminated
LCPK990899
Jan 11, 2012Heritage Labs International LLC
Appraise A1c Retail Kit, Product K7615, each kit packed in a box and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, and blood specimen collection supplies, forms, and i
Terminated
LCPK990899
Jan 11, 2012Heritage Labs International LLC
Heritage Labs Appraise A1c Diabetes Home Test , Product K7609, 24 kits/shipping carton (Product K7609), each kit packed in a box and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 507
Terminated
LCPK990899
Jan 11, 2012Heritage Labs International LLC
Heritage Labs Appraise Diabetes A1c Test , 24 kits/shipping carton (Product K7604), each kit packed in a box and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, and bloo
Terminated
LCPK990899
Jan 11, 2012Heritage Labs International LLC
Reli On Hemoglobin A1c Test (Replacement), Product K7603, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, and blood specimen col
Terminated
LCPK990899
Jan 11, 2012Heritage Labs International LLC
Heritage Labs Appraise Diabetes A1c Test , 12 kits/shipping carton (Product K7602), each kit packed in a box and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, and bloo
Terminated
LCPK990899

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