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
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 14, 2010 | K082275 | CLOVER A1C/GLYCOSYLATED HEMOGLOBIN MONITOR & BLOOD GLUCOSE MONITOR, MODEL IGM-0023 Infopia Co, Ltd. | LCP |
| Dec 11, 2009 | K091711 | S- TEST HEMOGLOBIN ALC (HBA1C), MODEL RC0023 Alfa Wassermann Diagnostic Technologies, Inc. | LCP |
| Jul 27, 2009 | K090699 | VARIANT II TURBO HBA1C KIT KIT-20 AND WASH/DILUENT SOLUTION SET, MODELS 270-2455, 270-2730 Bio-Rad Laboratories, Inc. | LCP |
| Jun 11, 2009 | K091400 | MODIFICATION TO AVIE A1C TEST SYSTEM Mec Dynamics Corp | LCP |
| May 14, 2009 | K090413 | A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT, PROFESSIONAL USE) MODEL 3021, A1CNOW SELF CHEC Bayer Healthcare, LLC | LCP |
| Mar 20, 2009 | K081269 | AVIE A1C TEST SYSTEM Mec Dynamics Corp | LCP |
| Jan 8, 2009 | K081895 | ADVIA CHEMISTRY HEMOGLOBIN A1C, ADVIA CHEMISTRY A1C CALIBRATORS Siemens Medical Solutions Diagnostics | LCP |
| Oct 17, 2008 | K073309 | ABX PENTRA HBA1C WB, CALIBRATOR, CONTROL AND HEMOLYSIS REAGENT Horiba Abx, FR | LCP |
| Sep 16, 2008 | K071132 | G8 AUTOMATED HPLC ANALYZER, MODEL HLC-723 G8 Tosoh Bioscience, Inc. | LCP |
| May 23, 2008 | K080618 | DIRECT HBA1C, FRUCTOSAMINE, GLUCOSE OXIDASE LIQUID Jas Diagnostics, Inc. | LCP |
| Apr 18, 2008 | K072714 | TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST SYSTEM Roche Diagnostics Corp. | LCP |
| Mar 17, 2008 | K072686 | AXSYM HBA1C REAGENTS, AXSYM HBA1C CALIBRATORS, AXSYM HBA1C CONTROLS Axis-Shield Diagnostics, Ltd., GB | LCP |
| Nov 26, 2007 | K062658 | PRIMUS A1CARE ASSAY Primus Corp. | LCP |
| Oct 9, 2007 | K071466 | DCA VANTAGE, MODEL 5075 Siemens Medical Solutions Diagnostics | LCP |
| Jun 25, 2007 | K070819 | VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM, AND VARIANT II TURBO LINK HEMOGLOBIN TESTING WITH MODEL, 270-2716, Bio-Rad Laboratories Inc., Clinical Systems Divisi | LCP |
| May 7, 2007 | K070452 | VARIANT II HEMOGLOBIN A1C PROGRAM WITH MODELS 270-2101NU Bio-Rad Laboratories, Inc. | LCP |
| Apr 17, 2007 | K063306 | ACE HEMOGLOBIN A1C REAGENT, MODEL ACI-21, HEMOGLOBIN A1C CALIBRATORS, MODEL S2-72, HEMOGLOBIN A1C CONTROLS, MODEL C2-72 Alfa Wassermann, Inc. | LCP |
| Apr 9, 2007 | K070734 | MODIFICATION TO: DIRECT ENZYMATIC HBA1C ASSAY KIT, MODEL# DZ168A, DZ168A-CAL, DZ168A-CON Diazyme Laboratories | LCP |
| Mar 21, 2007 | K063209 | HBA1C; CALIBRATOR; CONTROL NORMAL, CONTROL ABNORMAL Thermo Electron OY, FI | LCP |
| Dec 27, 2006 | K063643 | MODIFICATION TO VARIANT II: HEMOGLOBIN A1C PROGRAM, BETA-THALASSEMIA SHORT PROGRAM AND TOTAL GHB PROGRAM Bio-Rad Laboratories Inc., Clinical Systems Divisi | LCP |
| Dec 1, 2006 | K063400 | VARIANT II TURBO HEMOGLOBIN A1C PROGRAM, HEMOGLOBIN TESTING SYSTEM WITH CDM 4.0 Bio-Rad Laboratories, Inc. | LCP |
| Apr 6, 2006 | K060650 | VITROS CHEMISTRY PRODUCTS D%A1C REAGENT KIT, MODEL 680 2314; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 18, MODEL 680 1702 Ortho-Clinical Diagnostics, Inc. | LCP |
| Feb 3, 2006 | K053411 | DRI HEMOGLOBIN A1C ASSAY AND CALIBRATORS Microgenics Corp. | LCP |
| Jan 20, 2006 | K060001 | D-10 HEMOGLOBIN A1C PROGRAM; D-10 DUAL PROGRAM Bio-Rad Laboratories, Inc. | LCP |
| Sep 30, 2005 | K052464 | TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST Roche Diagnostics Corp. | LCP |
| Aug 8, 2005 | K051200 | HEMOGLOBIN A1C REAGENT SET Teco Diagnostics | LCP |
| Jul 22, 2005 | K050574 | AFINION HBALC Axis-Shield Poc AS | LCP |
| Jun 28, 2005 | K050178 | HBA1C ENZYMATIC ASSAY General Atomics | LCP |
| Jun 13, 2005 | K051321 | INVIEW Metrika, Inc. | LCP |
| Nov 17, 2004 | K042459 | SYNCHRON LX SYSTEMS HEMOGLOBIN A1C2 (HBA1C2) REAGENT Beckman Coulter, Inc. | LCP |
| Oct 29, 2004 | K042193 | DIAZYME GLYCATED SERUM PROTEIN ENZYMATIC ASSAY KIT Diazyme Laboratories | LCP |
| Oct 15, 2004 | K031296 | LIQUI-HEME GLYCO A1C ASSAY Biodiagnostic Intl | LCP |
| Sep 9, 2004 | K041764 | THE VITROS 5,1 FS CHEMISTRY SYSTEM Ortho-Clinical Diagnostics | LCP |
| Aug 16, 2004 | K041635 | G5 I HBA1C TEST, G5 II HBA1C TEST Provalis Diagnostics , Ltd. | LCP |
| Jun 9, 2004 | K041444 | BIO-RAD D-10 DUAL PROGRAM Bio-Rad Laboratories, Inc. | LCP |
| Apr 15, 2004 | K040872 | VARIANT II HEMOGLOBIN A1C Bio-Rad Laboratories, Inc. | LCP |
| Feb 9, 2004 | K033674 | MULTIGENT HEMOGLOBIN A1C (REAGENTS), HB A1C CALIBRATORS AND HB A1C CONTROLS Seradyn, Inc. | LCP |
| Dec 23, 2003 | K033847 | A1CNOW FOR HOME AND PROFESSIONAL USE Metrika, Inc. | LCP |
| Nov 14, 2003 | K031380 | OLYMPUS HBA1C REAGENT, (CATALOG NUMBER OSR6192), OLYMPUS HBA1C CALIBRATOR, (CATOLOG NUMBER ODC3032) Olympus America, Inc. | LCP |
| Nov 3, 2003 | K031042 | ATAC HEMOGLOBIN A1C REAGENT KIT Clinical Data, Inc. | LCP |
| Sep 2, 2003 | K030553 | ARKIT HBA1C Arkray, Inc. | LCP |
| Aug 27, 2003 | K031043 | D-10 HEMOGLOBIN A1C Bio-Rad Laboratories, Inc. | LCP |
| Aug 6, 2003 | K031539 | HEMOGLOBIN A1C REAGENT SET Pointe Scientific, Inc., | LCP |
| May 2, 2003 | K023654 | GLYCA-DIRECT FRUCTOSAMINE Polymedco, Inc. | LCP |
| Jan 13, 2003 | K023763 | RANDOX FRUCTOSAMINE, FRUCTOSAMINE CALIBRATOR, FRUCTOSAMINE CONTROLS Randox Laboratories, Ltd., GB | LCP |
| Dec 13, 2002 | K022661 | A1CNOW FOR HOME USE Metrika, Inc. | LCP |
| Nov 26, 2002 | K021897 | RANDOX HAEMOGLOBIN A1C Randox Laboratories, Ltd., IE | LCP |
| Jun 14, 2002 | K021484 | HEMOGLOBIN A1C CONTROL Canterbury Scientific , Ltd., NZ | LCP |
| Apr 24, 2002 | K020532 | POLYMEDCO HBA1C TEST Polymedco, Inc. | LCP |
| Feb 15, 2002 | K020235 | A1CNOW FOR PROFESSIONAL USE Metrika, Inc. | LCP |
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