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)
Top companies in LCP
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Diabetes HbA1c Test Open, Classified |
LCP | None listed |
| May 27, 2025 | Mckesson Medical-Surgical Inc. Corporate Office ABBOTT RAPID DX N AMERICA LLC HBA1C HEMOGLOBIN AFINION GLYCTD (15TST/BX) TEST KIT. Open, Classified |
LCP | K171650 |
| Oct 24, 2024 | Polymer 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 |
LCP | K090413 |
| Aug 27, 2024 | Abbott Diagnostics Technologies AS Afinion 2 Analyzer, model #1116986, US refurbished, CLIA waived. Open, Classified |
LCP | K171650 |
| Mar 19, 2024 | Siemens Healthcare Diagnostics, Inc. DCA Systems HbA1c Reagent Kit Open, Classified |
LCP | K951361 |
| Feb 9, 2022 | Siemens Healthcare Diagnostics, Inc. Atellica CH Fructosamine (Fruc), Siemens Material Number 11097637 Open, Classified |
LCP | K131307 |
| Jun 30, 2020 | Siemens Healthcare Diagnostics, Inc. DCA Vantage Handheld Barcode Scanner - Zebra Model - Model # DS4308 -
HC0015BZZWW external accessory to DCA Vantage Analyzer US Terminated |
LCP | K071466 |
| Jun 5, 2020 | Siemens 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 |
LCP | K131307 |
| Jun 5, 2020 | Siemens 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 |
LCP | K131307 |
| Oct 5, 2018 | Tosoh 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 |
LCP | K021484 |
| Jul 13, 2018 | Tosoh 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 |
LCP | K131580 |
| Jun 6, 2018 | Tosoh 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 |
LCP | K100304 |
| Mar 5, 2018 | Tosoh 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 |
LCP | K100304 |
| Jun 7, 2017 | Randox 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 |
LCP | K021897 |
| Dec 2, 2016 | Polymer Technology Systems CVS Health At Home A1C Test Kit, Software Version Revision D, REF Number 3059 Terminated |
LCP | K090413 |
| Dec 2, 2016 | Polymer Technology Systems ReliOn FastA1C Test, Software Version Revision D, REF Number 3055 Terminated |
LCP | K090413 |
| Dec 2, 2016 | Polymer Technology Systems Walgreens At-Home A1C Test Kit, Software Version Revision D, REF Number 3056 Terminated |
LCP | K090413 |
| Dec 2, 2016 | Polymer Technology Systems A1CNow SELF CHECK (European), Software Version Revision D, REF Numbers 3054, 3062 Terminated |
LCP | K090413 |
| Dec 2, 2016 | Polymer Technology Systems A1CNow+ Systems (professional use product), Software Version Revision D, REF Numbers US: 3021, 3024;
EU: 3037, 3038, 3057, 3058 Terminated |
LCP | K090413 |
| Nov 11, 2016 | Roche Diagnostics Operations, Inc. Tina-Quant Hemoglobin A1c Gen. 2
Hemoglobin A1c test
Catalog number 04528123190 / 05401640190 Terminated |
LCP | K072714 |
| Jul 20, 2016 | Siemens 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 |
LCP | K110934 |
| Jan 27, 2016 | Bio-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 |
LCP | K060001 |
| Nov 25, 2015 | Siemens 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 |
LCP | K110934 |
| Jul 14, 2015 | Tosoh 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 |
LCP | K011434 |
| Nov 21, 2014 | Siemens 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 |
LCP | K102045 K102510 |
| Oct 24, 2014 | Siemens Healthcare Diagnostics, Inc. Dimension Vista HbA1c Terminated |
LCP | K102045 |
| Mar 27, 2014 | Bio-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 |
LCP | K031043 |
| Feb 10, 2014 | Bio-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 |
LCP | K031043 |
| Jan 3, 2014 | Siemens 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 |
LCP | K102045 |
| Jan 3, 2014 | Siemens 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 |
LCP | K011852 |
| Nov 2, 2013 | Bayer 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 |
LCP | K090413 |
| Sep 3, 2013 | Siemens 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 |
LCP | K081895 |
| Jan 11, 2012 | Heritage 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 |
LCP | K990899 |
| Jan 11, 2012 | Heritage 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 |
LCP | K990899 |
| Jan 11, 2012 | Heritage 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 |
LCP | K990899 |
| Jan 11, 2012 | Heritage 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 |
LCP | K990899 |
| Jan 11, 2012 | Heritage 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 |
LCP | K990899 |
| Jan 11, 2012 | Heritage 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 |
LCP | K990899 |
| Jan 11, 2012 | Heritage 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 |
LCP | K990899 |
| Jan 11, 2012 | Heritage 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 |
LCP | K990899 |
| Jan 11, 2012 | Heritage 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 |
LCP | K990899 |
| Jan 11, 2012 | Heritage 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 |
LCP | K990899 |
| Jan 11, 2012 | Heritage 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 |
LCP | K990899 |
| Jan 11, 2012 | Heritage 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 |
LCP | K990899 |
| Jan 11, 2012 | Heritage 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 |
LCP | K990899 |
| Jan 11, 2012 | Heritage 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 |
LCP | K990899 |
| Jan 11, 2012 | Heritage 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 |
LCP | K990899 |
| Jan 11, 2012 | Heritage 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 |
LCP | K990899 |
| Jan 11, 2012 | Heritage 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 |
LCP | K990899 |
| Jan 11, 2012 | Heritage 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 |
LCP | K990899 |
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