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
Feb 15, 2002K020234A1CNOW FOR RX HOME USE
Metrika, Inc.
LCP
Jan 22, 2002K013465ACCU-BASE HEMOGLOBIN A1C SAMPLE COLLECTION KIT
Diabetes Technologies, Inc.
LCP
Nov 15, 2001K011852DIMENSION HAIC ASSAY, MODEL DF105
Dade Behring, Inc.
LCP
Nov 2, 2001K011933GLYCOSAL II HBA 1C TEST
Provalis Diagnostics , Ltd.
LCP
Oct 26, 2001K012410INFINITY HBA KIT, MODELS 537-A, 537-B
Sigma Diagnostics, Inc.
LCP
Oct 4, 2001K012525THERMO DMA FRUCTOSAMINE ASSAY, MODEL 7500-135/235
Thermo Dma, Inc.
LCP
Sep 18, 2001K011434G7 AUTOMATED HPLC ANALYZER
Tosoh Medics, Inc.
LCP
Jul 10, 2001K010748SYNCHRON SYSTEMS HEMOGLOBIN A1C REAGENT
Beckman Coulter, Inc.
LCP
Dec 19, 2000K003280VARIANT II TOTAL GHB
Bio-Rad
LCP
Dec 18, 2000K003120MODIFICATION TO INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN A1C
Roche Diagnostics Corp.
LCP
Sep 26, 2000K000885DRX HBA1C - FOR PRESCRIPTION HOME USE
Metrika, Inc.
LCP
Aug 21, 2000K001392GLYCOSAL HBA1C TEST
Provalis Diagnostics , Ltd.
LCP
Jul 26, 2000K000887DRX HBA1C
Metrika, Inc.
LCP
May 25, 2000K992085ABBOTT IMX GLYCATED HEMOGLOBIN II
Abbott Laboratories
LCP
May 22, 2000K993131NYCOCARD HBA1C GLYCOSYLATED HEMOGLOBIN ASSAY
Primus, Inc.
LCP
Mar 21, 2000K000239GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL
Genzyme Corp.
LCP
Dec 21, 1999K994045PRIMUS LIQUID CALIBRATOR FOR GHB/A1C LEVEL 1 AND LEVEL 2
Primus Corp.
LCP
Dec 21, 1999K993590FRUCTOSAMINE REAGENT SET, CALIBRATOR, AND CONTROL SET
Pointe Scientific, Inc.,
LCP
Dec 21, 1999K990899HEMOCHEK-A1C SAMPLE COLLECTION KIT
Osborn Group, Inc.
LCP
Dec 16, 1999K991246FRUCTOSAMINE, MODEL FR 106-01
A.P. Total Care, Inc.
LCP
Nov 26, 1999K991850SAFE AT-HOME TEST KIT FOR MONITORING HEMOGLOBIN ALC
Biosafe Laboratories, Inc.
LCP
Nov 12, 1999K992921PRIMUS LIQUID CONTROL FOR GHB/ALC LEVEL I AND LEVEL II
Primus Corp.
LCP
Nov 1, 1999K991483ABBOTT ARCHITECT GLYCATED HEMOGLOBIN
Abbott Laboratories
LCP
Sep 30, 1999K990992INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN ALC
Roche Diagnostics Corp.
LCP
Jan 28, 1999K984529HEMOCHEK SAMPLE COLLECTION KIT
Osborn Laboratories, Inc.
LCP
Dec 17, 1998K984268VARIANT II HEMOGLOBIN A1C PROGRAM
Bio-Rad
LCP
Nov 30, 1998K983172ACCU-BASE HEMOGLOBIN A1C SAMPLE COLLECTION KIT
Diabetes Technologies, Inc. (Dti)
LCP
Nov 25, 1998K983726GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL
Genzyme Corp.
LCP
Nov 20, 1998K983253PRECISION A1C HOME HBA1C SAMPLE COLLECTION KIT
Medisense, Inc.
LCP
Aug 13, 1998K980888GLYCACOR
Exocell, Inc.
LCP
Jun 15, 1998K973365AIC - CHEK (HBAIC-I)
Express-Med, Inc.
LCP
May 13, 1998K974491ACCU-CHEK A1C HEMOGLOBIN TEST
Boehringer Mannheim Corp.
LCP
Nov 24, 1997K973696SYNCHRON SYSTEM HEMOGLOBIN ALC REAGENT
Beckman Instruments, Inc.
LCP
Sep 25, 1997K972265A1C 2.2 PLUS - AUTOMATED GLYCOHEMOGLOBIN ANALYZER
Tosoh Medics, Inc.
LCP
Sep 5, 1997K971919EZCHEK/HBA BLOOD COLLECTION KIT
Flexsite Diagnostics, Inc.
LCP
Jun 13, 1997K962597LXN FRUCTOSAMINE TEST SYSTEM
Lxn Corp.
LCP
Apr 22, 1997K963844HYDRAGEL 15 HB A1C KIT
Morax
LCP
Sep 27, 1996K961674ROCHE UNIMATE FRUCTOSAMINE REAGENT
Roche Diagnostic Systems, Inc.
LCP
Jun 13, 1996K955087HEMOGLOBIN ALC (HBA1C) & TOTAL ASSAYS FOR THE TECHNICON RA/OPERA SYSTEMS IN-VITRO DIAGNOSTIC SYSTEMS
Bayer Corp.
LCP
Feb 9, 1996K952337ROCHE UNIMATE 3/UNIMATE 5 HBA1C, HBA1C CALIBRATOR, HBA1C CONTROLS N & P
Roche Diagnostic Systems, Inc.
LCP
Jul 11, 1995K946274COLUMNMATE II GHB AFFINITY REGENERABLE COLUMN
Helena Laboratories
LCP
Jun 9, 1995K936285ABBOTT VISION GLYCATED HB, MODIFICATION
Abbott Laboratories
LCP
May 5, 1995K951361DCA 2000 SYSTEM FOR HEMOGLOBIN A1C
Heraeus Kulzer, Inc.
LCP
Apr 14, 1995K941616VARIANT TOTAL GHB PROGRAM
Bio-Rad
LCP
Oct 11, 1994K934070TINA-QUANT HEMOGLOBIN A1C
Boehringer Mannheim Corp.
LCP
Sep 14, 1994K942009PRIMUS RAPID GEL 100 GLYCATED HEMOGLOBIN ASSAY
Primus Corp.
LCP
Jul 19, 1994K940971AMES DCA 2000 HEMOGLOBIN ALC CONTROLS
Heraeus Kulzer, Inc.
LCP
Apr 5, 1994K935613RADIAS MONOCLONAL HBA 1C ASSAY
Bio-Rad
LCP
Mar 22, 1994K936204GLYCATED HEMOGLOBIN CALIBRATORS
Primus Corp.
LCP
Mar 15, 1994K940143GLYCATED HEMOGLOBIN CONTROLS
Primus Corp.
LCP

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