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
Nov 5, 1993K931183GLYCOHEMOGLOBIN
Teco Diagnostics
LCP
Sep 9, 1993K933287745 GLYCOMAT
Drew Scientific , Ltd., GB
LCP
Aug 19, 1993K930823PROTEIN-BOUND GLUCOSE ASSAYN KIT
Diagnostic Specialties
LCP
Mar 29, 1993K926469VARIANT(TM) HEMOGLOBIN A 1C PROGRAM
Bio-Rad
LCP
Jan 12, 1993K925204BECKMAN DIATRAC HEMOGLOB A1C ELECTRO KIT, MODIFIED
Beckman Instruments, Inc.
LCP
Sep 29, 1992K921831IMX(R) GLYCATED HEMOGLOBIN
Abbott Laboratories
LCP
Aug 17, 1992K920820MODIFICATION COLUMNMATE
Helena Laboratories
LCP
Aug 4, 1992K920397REFLAB SYSTEM PACK LIQUID FRUCTOSAMINE REAGENT
Medical Analysis Systems, Inc.
LCP
Jul 28, 1992K920449POINTE 750 GLYCOMETER
Pointe Scientific, Inc.,
LCP
Jul 21, 1992K920198GLYCOMAT HAEMOGLOBIN ANALYSER
Drew Scientific , Ltd., GB
LCP
Jul 10, 1992K921676COLUMNMATE II
Helena Laboratories
LCP
Jun 9, 1992K921305GLYCO-TEK AFFINITY COLUMN KIT
Helena Laboratories
LCP
Dec 2, 1991K913614FRUCTOSAMINE ABG21 TEST SYSTEM
Boehringer Mannheim Corp.
LCP
Oct 31, 1991K912748BINAX EQUATE(R) GLYCOHEMOGLOBIN 3 MINUTE TEST KIT
Binax, Inc.
LCP
Sep 23, 1991K905709BECKMAN DIATRAC HEMOGLOBIN A ELECTROPHORESIS KIT
Beckman Instruments, Inc.
LCP
Sep 5, 1991K911625AMES DCA 2000TM ANALYZER AND REAGENT SYSTEM
Heraeus Kulzer, Inc.
LCP
Feb 7, 1991K904027ABBOTT VISION(TM) GLYCATED HB
Abbott Laboratories
LCP
Jan 15, 1991K905513GLYC-AFFIN(TM)-GA
Isolab, Inc.
LCP
Dec 26, 1990K904814GLYC-AFFIN GP
Isolab, Inc.
LCP
Sep 11, 1990K896830OPTIMATE HEMOGLOBIN A1C
Heraeus Kulzer, Inc.
LCP
Jul 24, 1990K902457ABNORMAL GLYCOHEMOGLOBIN CONTROL
Analytical Control Systems, Inc.
LCP
Jul 24, 1990K902455ACS NORMAL GLYCOHEMOGLOBIN CONTROL (A1C HGB)
Analytical Control Systems, Inc.
LCP
Jun 28, 1990K896582DIABETES CARE(TM) TEST PACKAGE FOR THE CLC 330(TM)
Primus, Inc.
LCP
Jun 15, 1990K901414COLUMNMATE (AUTOMATED COLUMN SYSTEM) 1580, 1581
Helena Laboratories
LCP
Jun 12, 1990K900718ROTAG FRUCTOSAMINE (GLYCATED PROTEIN) ASSAY
Roche Diagnostic Systems, Inc.
LCP
Dec 11, 1989K896335CLP GLYCOSYLATED HEMOGLOBIN CONTROL-NR
Creative Laboratory Products, Inc.
LCP
Dec 11, 1989K896334CLP GLYCOSYLATED HEMOGLOBIN CONTROL-ER
Creative Laboratory Products, Inc.
LCP
Dec 7, 1989K895661GLYCOTEST II GLYHB ASSAY KIT
Pierce Chemical Co.
LCP
Oct 23, 1989K893453GLYCABEN
Exocell, Inc.
LCP
Jun 20, 1989K893224REP GLYCO-8 KIT, #3208/REP GLYCO-16 KIT, #3207
Helena Laboratories
LCP
Jun 16, 1989K891235PRIMUS MODEL CLC 330
Primus, Inc.
LCP
Mar 28, 1989K884184SIGMA PROCEDURE NO. 465 FOR DETER. OF FRUCTOSAMINE
Sigma Diagnostics, Inc.
LCP
Dec 27, 1988K884315LABILE LYSING REAGENT
Helena Laboratories
LCP
Nov 22, 1988K880673GHB SAMPLE PAPER
Isolab, Inc.
LCP
Sep 30, 1988K881863REP GLYCO SYSTEM
Helena Laboratories
LCP
Aug 12, 1988K874749BINAX EQUATE GLYCOHEMOGLOBIN
Binax, Inc.
LCP
Aug 1, 1988K882222DETERMIN HEMOGLOBIN ALC/HI PERF LIQ CHROMATOGRAPHY
Bio-Rad
LCP
Aug 1, 1988K882051BIO-RAD HEMOGLOBIN DETECTOR
Bio-Rad
LCP
May 6, 1988K880698TITAN GEL-PC GLYCO-HEME(TM) SYSTEM
Helena Laboratories
LCP
Apr 5, 1988K873428GLYCO-PROBE GSP
Isolab, Inc.
LCP
Feb 17, 1988K875354UNISTEP CAPILLARY BLOOD COLLECTION SYSTEM
Ulster Scientific, Inc.
LCP
Dec 22, 1987K854010FRUCTOSAMINE TEST (ROCHE)
Roche Diagnostic Systems, Inc.
LCP
Sep 29, 1987K872852EAGLE DIAGNOSTICS GLYCOHEMOGLOBIN UNITIZED TEST
Sandare Chemical Co., Inc.
LCP
Jul 28, 1987K871679FOCUS-GHB
Awareness Technology, Inc.
LCP
Jul 6, 1987K871388MICROMAT MODEL 415 - BICHROMATIC FILTER PHOTOMETER
Bio-Rad
LCP
Apr 28, 1987K864643GLYCOSCREEN GLYCOSYLATED HEMOGLOBIN ASSAY KIT
Pacific Hemostasis
LCP
Sep 16, 1986K862371HEMOGLOBIN A1C BY COLUMN TEST (MICRO A1C)
Bio-Rad
LCP
Aug 19, 1986K861697SELF ASSURE/GHB (CAPILLARY-BLOOD COLLECTION KIT)
Awareness Technology, Inc.
LCP
Aug 8, 1986K862556SANDARE GLYCOHEMOGLOBIN PROCEDURE
Sandare Chemical Co., Inc.
LCP
May 16, 1986K860572GLYCOHEMOGLOBIN, IN-VITRO DIAGNOSTIC REAGENT SET
Pointe Scientific, Inc.,
LCP

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