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
Aug 19, 1985K852986GLYCO-SEP/ALC TEST KIT FOR SEPARAT OF HEMOGLOBIN
Clinical Technology Corp.
LCP
Jul 30, 1985K851636DIAMAT GLYCOSLATED HEMOGLOBIN ANALYZER SYSTEM
Bio-Rad
LCP
Jul 5, 1985K852111GLYCO-CHECK
Thyroid Diagnostics, Inc.
LCP
Oct 15, 1984K842689GLYCO-TEK AFFINITY COLUMN
Helena Laboratories
LCP
Jan 24, 1984K834294ELTRACHEM DIATRAC GLYCOSYLATED HEMOGLOB
Emd Chemicals, Inc.
LCP
Jan 18, 1984K833772AUTO AIC ANALYZER SYSTEM
Helena Laboratories
LCP
Jan 3, 1984K833805GLYCOGLOBIN KIT
Endocrine Sciences Products
LCP
Nov 3, 1983K833356GLYCO-JE,E CPMTRP;-NORMAL/ABNORMAL
Helena Laboratories
LCP
Sep 29, 1983K832775A-GENT GLYCOSYLATED HEMOGLOBIN
Abbott Laboratories
LCP
Aug 24, 1983K832087TITAN GEL GLYCO-HEME SYSTEM
Helena Laboratories
LCP
Aug 1, 1983K831837CLINOVATIVE II DIAGNOSTIC KIT
Pierce Chemical Co.
LCP
Jun 22, 1983K831478LYPHOCHEK HEMOGLOBIN AIC CONTROL HUMAN
Bio-Rad
LCP
Jun 16, 1983K830935HEMOGLOBIN ALC BY COLUMN TEST
Bio-Rad
LCP
Feb 1, 1983K823869GLYCO HB QUIK COLUMN PROCEDURE
Helena Laboratories
LCP
Dec 3, 1982K822867GLYC-AFFIN GLYCOHEMOGLOBIN ASSAY
Isolab, Inc.
LCP
Nov 16, 1982K822977HEMOGLOBIN ALC BY COLUMN TEST
Bio-Rad
LCP
Jun 2, 1982K821360GLYCO-GEL TEST KIT
Pierce Chemical Co.
LCP
Apr 8, 1982K820279GLYCO-GEL TEST KIT
Pierce Chemical Co.
LCP
Feb 12, 1982K820076GLYCO-SEP REAGENT TEST SET
Clin Tech Diagnostics Corp.
LCP
Sep 16, 1981K811567ORTHO* BI-LEVEL ASSAYED GLYCOH. CONTR. S
Ortho Diagnostic Systems, Inc.
LCP
Sep 16, 1981K810958GLYCOHEMOGLOBIN
Macomb Chemical Co.
LCP
Sep 9, 1981K812242CORDISNHYPERION HEMOGLOBIN A1 TEST SYS
Cordis Corp.
LCP
Jul 15, 1981K811710BIO.RAD HEMOGLOBIN A1 BY COLUMN TEST
Bio-Rad
LCP
May 8, 1981K811000ABNORMAL GLYCOSYLATED HEMOGLOBIN CONTROL
Corning Medical & Scientific
LCP
May 8, 1981K810714LANCER GLYCOSYLATED HEMOGLOBIN ASSAY
Sherwood Medical Co.
LCP
May 8, 1981K810638LANCER GLYCOSYLATED HEMOGLOBIN
Sherwood Medical Co.
LCP
Jan 21, 1981K803186NORMAL AND ELEVATED CONTROL FOR GLYCO.
Applied Clinical Research Laboratories
LCP
Jan 16, 1981K802832SANDARE GLYCOHEMOGLOBIN PROCEDURE
Sandare Chemical Co., Inc.
LCP
Dec 11, 1980K802721GLYCOHEMOGLOBIN IN WHOLE BLOOD
Sigma Chemical Co.
LCP
Dec 1, 1980K802432GLYCO-TROL HUMAN GLYCOSYLATED HOM. CONT.
Clin Tech Diagnostics Corp.
LCP
Oct 10, 1980K802233GLYCOSYLATED HEMOGLOBIN-SMC COLUMN
Helena Laboratories
LCP
Sep 26, 1980K800857HELENA GLYCOSYLATED HEMOGLOBIN QUIK METH
Helena Laboratories
LCP
Aug 12, 1980K801561GLYCOSYLATED HEMOGLOBIN KIT
Amersham Corp.
LCP
Jul 8, 1980K801422SANDARE LYOPHILIZED GLYCOHEMOGLOBIN CLS.
Sandare Chemical Co., Inc.
LCP
Jun 30, 1980K801289LEECO GLYCO-HEMOGLOBIN DIAG. TEST KIT
Leeco Diagnostics, Inc.
LCP
Apr 29, 1980K800794FAST HEMOGLOBIN CONTROL-LYOPHILIZED
Isolab, Inc.
LCP
Nov 30, 1979K792086GLYCO-SPIN
Applied Clinical Research Laboratories
LCP
Nov 13, 1979K791777CORNING GLYCOSYLATED HEMOGLOBIN SET
Corning Medical & Scientific
LCP
Oct 17, 1979K791642A-GENT GLYCOSPEC
Abbott Laboratories
LCP
Sep 27, 1979K791365FAST FLOW #60310
Hi Chem, Inc.
LCP
Aug 22, 1979K791428GLUCOHEMOGLOBIN CONTROL
Bd Becton Dickinson Vacutainer Systems Preanalytic
LCP
Jun 28, 1979K791135LYOPHILIZED G-HB QUIK COLUMN CONTROL
Helena Laboratories
LCP
Jun 28, 1979K791103LEECO GLYCO-HEMOGLOBIN DIAGNOSTIC KIT
Leeco Diagnostics, Inc.
LCP
Apr 23, 1979K790583QUIK COLUMN METHODOLOGY
Helena Laboratories
LCP
Jan 26, 1979K790046G-HB QUIK COLUMN CONTROL
Helena Laboratories
LCP
Dec 20, 1978K781948COLUMN TEST, HEMOGLOBIN A
Bio-Rad
LCP
Nov 7, 1978K781851HEMOGLOBIN, TESTING SYSTEM
Isolab, Inc.
LCP
Nov 7, 1978K780819GLYCOHEMOGLOBIN-SKREEN TEST KIT
Eppendorf-Brinkmann, Inc.
LCP
Nov 7, 1978K780573TECHNIQUE, CHROMATOGRAPHIC, HEMOGLOBIN
Bd Becton Dickinson Vacutainer Systems Preanalytic
LCP

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