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)
Jan 11, 2012Heritage Labs International LLC
Appraise Hemoglobin A1c Test , Product K7600, 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 sup
Terminated
LCPK990899
Jan 11, 2012Heritage Labs International LLC
Appraise A1C Test Pak Kit (Carolina Care Plan), Product K7400, 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 specim
Terminated
LCPK990899
Jan 11, 2012Heritage Labs International LLC
Appraise A1C Test Pak Kit (Alere), Product K7300, 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
Terminated
LCPK990899
Jan 11, 2012Heritage Labs International LLC
Appraise A1C Test Pak Kit (IBM Care Advantage), Product K7200, 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 specim
Terminated
LCPK990899
Jan 11, 2012Heritage Labs International LLC
Appraise A1C Test Pak Kit (Consumers Life Insurance Company), Product K7100, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, an
Terminated
LCPK990899
Jan 11, 2012Heritage Labs International LLC
Appraise A1C (Retail) Collection Kit, Product K7050, 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 collect
Terminated
LCPK990899
Jan 11, 2012Heritage Labs International LLC
Appraise A1C Test Pak Kit (Medical Mutual of Ohio), Product K7000, 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 sp
Terminated
LCPK990899
Jan 11, 2012Heritage Labs International LLC
Alere Blood Collection Kit (Carolina Care Plan), Product K6900, 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 speci
Terminated
LCPNone listed
Jan 11, 2012Heritage Labs International LLC
Alere Blood Collection Kit (Consumer Life Insurance), Product K6700, 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
Terminated
LCPK990899
Jan 11, 2012Heritage Labs International LLC
Nationwide DBS Collection Kit, Product K4003, 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 sup
Terminated
LCPK990899
Jan 11, 2012Heritage Labs International LLC
Appraise DBS Kit, Product K4002, 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 supplies, forms,
Terminated
LCPK990899
Jan 11, 2012Heritage Labs International LLC
Super Valu (Appraise) Combo Kit, Product A1773, each kit packed in a bag or envelope. (This kit has since changed to product A8302, which will be listed separately due to the new part number.) Each
Terminated
LCPK990899
Jan 11, 2012Heritage Labs International LLC
Heritage Labs Wellness Kits, Product A1769, each kit packed in a bag or envelope in bulk, 50 kits/shipping carton. Each kit contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-
Terminated
LCPK990899
Jan 11, 2012Heritage Labs International LLC
Heritage Labs Wellness Kits, Product A1768, each kit packed in a bag or envelope in bulk, 25 kits/shipping carton. Each kit contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-
Terminated
LCPK990899
Jan 11, 2012Heritage Labs International LLC
Heritage Labs Wellness Kits w/Purple Top, Product A1767, each kit packed in a bag or envelope in bulk, 50 kits/shipping carton. Each kit contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, ND
Terminated
LCPK990899
Jan 11, 2012Heritage Labs International LLC
Heritage Labs Wellness Single Kit/Bulk, Product A1751, each kit packed in a bag or envelope in bulk, 50 kits/shipping carton. Each kit contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC
Terminated
LCPK990899
Jan 11, 2012Heritage Labs International LLC
Benicomp Supplies Kit, Product A1740. Each kit contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, blood specimen collection supplies and forms packaged in a plastic pouch.
Terminated
LCPNone listed
Jan 11, 2012Heritage Labs International LLC
Heritage Labs St. Jude Childhood Cancer Study Kit, Product A1185. Each kit contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0 and blood specimen collection supplies. Blood s
Terminated
LCPNone listed
Jan 11, 2012Heritage Labs International LLC
Heritage Labs DBS/Urine Collection Kit, Product A1101, packed in bags in bulk, 25 kits/shipping carton. Each kit contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, blood sp
Terminated
LCPK990899
Oct 7, 2011Bio-Rad Laboratories, Inc.
VARIANT II TURBO LINK Hemoglobin A1c Program Reorder Pack, 1600 tests. For the determination of Hemoglobin A1c in human whole blood. Contents: 1. Elution Buffer A, 1 x 2500 mL Bis-Tris Phosphate Buff
Terminated
LCPK070819
Oct 7, 2011Bio-Rad Laboratories, Inc.
VARIANT II TURBO LINK Hemoglobin A1c Program Buffer Set. Made in United States. Bio-Rad Laboratories, Hercules, CA 94547. Percentage determination of hemoglobin A1c in human whole blood using ion-e
Terminated
LCPK070819
Oct 7, 2011Bio-Rad Laboratories, Inc.
VARIANT / VARIANT II B-thalassemia Short Program Elution Buffer 2,. Made in United States. Bio-Rad Laboratories, Hercules, CA 94547. Percentage determination of hemoglobin A1c in human whole blood u
Terminated
LCPK924122
K991127
Oct 7, 2011Bio-Rad Laboratories, Inc.
VARIANT B-thalassemia Short Program Reorder Pack, 500 Tests, For the separation and determination of HbA and HbF and as an aid in the identification of abnormal hemoglobins in whole blood. IVD, Made
Terminated
LCPK991127
Oct 7, 2011Bio-Rad Laboratories, Inc.
VARIANT B-thalassemia Short Program Reorder Pack, 250 Tests, For the separation and determination os HbA and HbF and as an aid in the identification of abnormal hemoglobins in whole blood. IVD, Made
Terminated
LCPK991127
Oct 7, 2011Bio-Rad Laboratories, Inc.
VARIANT II TURBO Hemoglobin A1c Program Buffer B, Made in United States. Bio-Rad Laboratories, Hercules, CA 94547. Percentage determination of hemoglobin A1c in human whole blood using ion-exchange h
Terminated
LCPK040872
Oct 7, 2011Bio-Rad Laboratories, Inc.
VARIANT II TURBO Hemoglobin A1c Program Reorder Pack, 2000 tests, IVD, Made in United States. Kit contains: 1. Elution Buffer A 3 x 2500 mL, Bis-Tris Phosphate Buffer 2. Elution Buffer B 1 x 1500 mL
Terminated
LCPK040872
Oct 7, 2011Bio-Rad Laboratories, Inc.
VARIANT II TURBO Hemoglobin A1c Program Reorder Pack, 1600 tests, IVD, Made in United States. Kit contains: 1. Elution Buffer A 3 x 2500 mL, Bis-Tris Phosphate Buffer 2. Elution Buffer B 1 x 1500 mL
Terminated
LCPK040872
Oct 7, 2011Bio-Rad Laboratories, Inc.
D-10 Hemoglobin A1c Program Elution Buffer 2: Bio-Rad Laboratories, Hercules, CA 94547. Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid ch
Terminated
LCPK031043
Oct 7, 2011Bio-Rad Laboratories, Inc.
D-10 Hemoglobin A1c Supplemental Reagent Pack: Bio-Rad Laboratories, Hercules, CA 94547. Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid c
Terminated
LCPK031043
Oct 7, 2011Bio-Rad Laboratories, Inc.
D-10 Hemoglobin A1c Program Reorder Pack; 400 tests; For the determination of Hemoglobin A1c in human whole blood. IVD Contents: 1. Elution Buffer 1 2 x 2000 ml Bio-Tris Phosphate Buffer 2. Elution
Terminated
LCPK031043
Sep 6, 2011Bio-Rad Laboratories, Inc.
VARIANT II TURBO Link Hemoglobin A1c Program Reorder Pack. Calibrator/Diluent Set. IVD. Kit components: Elution Buffer A, 2 x 2500 mL Elution Buffer B, 1 x 2100 mL Wash/Diluent Solution, 1 x 2500 mL C
Terminated
LCPK070819
Jul 27, 2011Bio-Rad Laboratories Inc
D-10 Dual Program Reorder Pack; contains 400 HbA1c or 200 HbA2/F/A1c tests. Kits include Elution Buffer 1 and 2; Calibrator 1 & 2. Bio-Rad Laboratories Inc. Hercules, CA. Product Usage: Short Prog
Terminated
LCPK041444
May 10, 2011Beckman Coulter Inc.
Beckman Coulter HbA1c APT (Hemoglobin A1c, Whole Blood Application), Part Number: OSR61177, Lot Numbers: 9390 & 9472 Immuno-inhibition test for the quantitative determination of HbA1c (Hemoglobin A1c)
Terminated
LCPK031380
Apr 13, 2011Bio-Rad Laboratories, Inc., Hercules, CA
Bio Rad brand D-10 Hemoglobin A1c Program Reorder Pack, which contains Update Kit D-10 A1c Program Diskette; Model Numbers: 220-0101 (Reorder Pack); 220-0115 (Program Diskette); Distributed and manufa
Terminated
LCPK031043
Apr 11, 2011Bio-Rad Laboratories Inc
Bio Rad brand VARIANT II TURBO Hemoglobin Alc Program, 1600 and 2000 tests Cartridge Sets. Catalog Numbers: 270-2417 and 270-2415; Distributed and Manufactured by: Bio-Rad Laboratories, Inc. Hercules,
Terminated
LCPNone listed
Apr 6, 2011Bio-Rad Laboratories Inc
Device brochure, labeled in part : BIO -RAD***L70242709 VARIANT TM II TURBO***Hemoglobin A 1C***Cartridge Set, Cartridge Set, Analytical Cartridge, Guard Cartridge Insert***UNITED STATES, Bio-Rad Labo
Terminated
LCPK063400
Feb 17, 2011Bio-Rad Laboratories Inc
Bio Rad brand VARIANT II TURBO Hemoglobin A1c Program Reorder Pack, Model Number/Catalog No.: 270-2417, which contains the update kit CD-ROM, Model/Catalog No.: 270-2423, Distributed and Manufactured
Terminated
LCPK040872
K063400
Feb 15, 2011Bio-Rad Laboratories Inc
Bio-Rad Variant II Turbo Link Hemoglobin Testing System, including Hemoglobin A, Program Reorder Pack 1600 Tests, Program Buffer A, Buffer B, Cartridge Set, Analytical Cartridge, Guard Cartridge, Cali
Terminated
LCPK070819
Oct 22, 2010Bio-Rad Laboratories Inc
in2it (I) and (II) System A1c Test cartridges and in2it Self Test System A1c Test Cartridges, for use with the in2it (I) and (II) self test system analyzer, manufactured by Bio-Rad, Flintshire, UK The
Terminated
LCPK041635
Oct 21, 2010Bio-Rad Laboratories Inc
in2it (I) A1c Test Cartridges (Catalog 281-0001EX) and in2it (II) A1c Test Cartridges (Catalog 281-0001), manufactured by Bio-Rad Laboratories Deeside Ltd., Flintshire, UK, distributed by Bio-Rad Labo
Terminated
LCPK041635
Jun 25, 2010Bio-Rad Laboratories Inc
VARIANT II TURBO Hemoglobin Testing System with CDM 3.6T Software Version 3.5; Model Number: 270-2600; Product is manufactured and distributed by Bio-Rad Laboratories, Diagnostics Group, Hercules, CA.
Terminated
LCPK984268
Jun 25, 2010Bio-Rad Laboratories Inc
VARIANT II Hemoglobin Testing System with CDM 3.5 Software Version 3.5; Model Number: 270-2000; Product is manufactured and distributed by Bio-Rad Laboratories, Diagnostics Group, Hercules, CA. Provi
Terminated
LCPK984268
Mar 5, 2010Bio-Rad Laboratories Inc
Bio-Rad VARIANT II Hemoglobin A1c Program Recorder Pack with Calibrator/Diluent Set, Model Number 270-2101NU Manufactured by Bio-Rad Laboratories, Hercules, CA
Terminated
LCPK070452
Feb 26, 2010Bio-Rad Laboratories Inc
Variant II Turbo Hemoglobin A1c Program, model number 270 2417, manufactured by Bio-Rad Laboratories, Inc, Hercules, CA. Intended Use: For the percent determination of hemoglobin A1c in human whole
Terminated
LCPK063400
May 19, 2009Bio-Rad Laboratories Inc
Bio-Rad Variant II Hemoglobin Testing System with CDM v 4.0, model number 270-2000, Manufactured by Bio-Rad Laboratories, Hercules, CA Measurement of percent hemoglobin Alc is effective in monitoring
Terminated
LCPK063643
Mar 24, 2009Bio-Rad Laboratories Inc
Bio-Rad Variant II TURBO Hemoglobin Testing System with CDM v 4.0, model number 270-2600, Manufactured by Bio-Rad Laboratories, Hercules, CA Provides an integrated method for sample preparation, sepa
Terminated
LCPK063400
Dec 17, 2008Alfa Wassermann, Inc.
ACE and ACE Alera Hemoglobin A1C : EZA1C Reagent, EZA1C Controls, and EZA1C Calibrators. Hemoglobin A1c (EZA1c) Calibrators for Calibration of the Enzymatic Hemoglobin A1c (HbA1c) Assay. For in vitr
Terminated
LCPK070734
Sep 23, 2008Cholestech Corp
Cholestech GDX A1C Test Cartridge. The Cholestech GDX A1C Test is an in-vitro diagnostic test that measures hemoglobin A1c (HbA1c).
Terminated
LCPK041635
Aug 31, 2007Metrika Inc
A1CNOW+ with sampler 10-Test Kits (Product No: 3022), Metrika, Inc., Sunnyvale, CA 94085. (This test provides quantitative measurement of the percent of glycated hemoglobin (%A1C) levels in capillary
Terminated
LCPK051321
Nov 18, 2005Provalis Diagnostics
Product is in2it A1C In-Office Analyzer Test Cartridge. Catalogue number is 902074P (Test Cartridges) which may then be packaged as a consumables pack (902079D) or a starter pack (901077N). Product
Terminated
LCPK041635

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