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Panels › Clinical Chemistry › Product code CGA · Class 2

Glucose Oxidase, Glucose

Regulation 862.1345

1510(k)s in 12 months (401 all time)
0recalls in 12 months (89 all time)
79recalls that name a 510(k)
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Top companies in CGA

Decided510(k)Device and applicantCode
Jan 18, 1982K813555GLUCOSE ENZYME-COLOR REAGENT SET
Biorent Diagnostic, Inc.
CGA
Dec 31, 1981K813412GLUCOSE ENZYME-COLOR REAGENT SET
Diagnostic Specialties
CGA
Dec 22, 1981K813370ELECTROLYTE GEL
Hi Chem, Inc.
CGA
Dec 17, 1981K812866ASTRA REAGENT CONCENTRATE SYSTEM
Nobel Scientific Industries, Inc.
CGA
Dec 3, 1981K813168LIQUIZYME GLUCOSE REAGENT
American Research Products Co.
CGA
Aug 31, 1981K812258ACR ENZYMATIC GLUCOSE OXIDASE
Harleco
CGA
Aug 13, 1981K811165GLUCOSE OXIDASE RATE REAGENT
Chem-Elec, Inc.
CGA
Jul 23, 1981K811882KING DIAGNOSTICS GLUCOSE TEST
King Diagnostics, Inc.
CGA
Jul 1, 1981K811592LIQUIZYME SINGLE SOLUTION GLUCOSE REAG
Amresco, Inc.
CGA
May 29, 1981K811392AMES SERA-PAK GLUCOSE REAGENT
Miles Laboratories, Inc.
CGA
Apr 29, 1981K811074GLUCOSE REAGENT-ENZYMATIC-COLOR 500
Reagents Applications, Inc.
CGA
Apr 29, 1981K810993GLUCOSCAN TEST STRIPS
Lifescan, Inc.
CGA
Mar 31, 1981K810674GLUCOSE OXIDASE
Pointe Scientific, Inc.,
CGA
Mar 31, 1981K810639SERALYZER SYSTEM
Miles Laboratories, Inc.
CGA
Mar 13, 1981K810567GERMCO TEST R GLUCOSE TEST KIT
Fermco Biochemics, Inc.
CGA
Oct 10, 1980K801897GLUCOSE DIAGNOSTIC REAGENT
Connecticut Diagnostics, Ltd.
CGA
Aug 27, 1980K801600GLUCOSE (TRINDER) REAGENT
Gilford Diagnostics
CGA
Aug 20, 1980K801663SERALYZER GLUCOSE REAGENT STRIPS
Miles Laboratories, Inc.
CGA
May 28, 1980K800687REAGENT FOR DETERM. GLUCOSE IN H/SERUM
Diagnostic Solutions, Inc.
CGA
May 23, 1980K801071LANCER GLUCOSE RATE REAGENT KIT
Sherwood Medical Industries
CGA
Apr 4, 1980K800589GLUCOSE OXIDASE REAGENT
Nobel Scientific Industries, Inc.
CGA
Feb 21, 1980K800200LINEAR ENZYMATIC GLUCOSE SYSTEM
Simmler, Inc.
CGA
Feb 5, 1980K800070GLUCOSE OXIDASE REAGENT KIT
Fisher Scientific Co., LLC
CGA
Jan 16, 1980K792534NEOCHROME II GLUCOSE, #4044
American Monitor Corp.
CGA
Dec 7, 1979K792398ELVI GLUCOSE
Volu Sol Medical Industries
CGA
Oct 17, 1979K791989TECHNICON C202 SYSTEM
Technicon Instruments Corp.
CGA
Oct 1, 1979K791869GLUCOSE OXIDASE (FRINDER) KIT
Mid Tech, Inc.
CGA
Sep 24, 1979K791669GLUCOSE OXIDASE REAGENT SET
Macomb Chemical Co.
CGA
Sep 17, 1979K791685GLUCOSE REAGENT
Hi Chem, Inc.
CGA
Sep 4, 1979K791066GLUCOSE GOD-PAP TRINDER METHOD TEST KIT
Fermco Biochemics, Inc.
CGA
Jan 17, 1979K781945GLUCOSE OXIDASE REAGENT
Fermco Biochemics, Inc.
CGA
Aug 31, 1978K781342GLUCOSE TEST
Wako Intl., Inc.
CGA
Aug 31, 1978K781307GLUCOSE DETERM. KIT
Analytical & Research Chemicals, Inc.
CGA
Aug 14, 1978K781075STATTEK-GLUCOSE LOW LEVEL
Boehringer Mannheim Corp.
CGA
Jun 19, 1978K780393BIOSTATOR GLUCOSE ANALYZER
Miles Laboratories, Inc.
CGA
May 3, 1978K780512AUTO/STAT KIT
Pierce Chemical Co.
CGA
Mar 3, 1978K772308AUTOZYME GLUCOSE OXIDASE (TRINDER)
J.T. Baker Chemical Co.
CGA
Feb 13, 1978K780093GLUCOSE REAGENT FOR GLUCOSE ANALYZER
Harleco
CGA
Oct 18, 1977K771754GLUCOSE REAGENT FOR GLUC. ANALYZER
Harleco
CGA
Sep 12, 1977K771471MULTISTAT III GLUCOSE TEST
Instrumentation Laboratory CO
CGA
Jul 21, 1977K771059DIAG. OZYRATE GLUCOSE REAG. SET
J.T. Baker Chemical Co.
CGA
Jul 15, 1977K771000TRENDAR
Hi Chem, Inc.
CGA
Jul 11, 1977K771001STATZYME GLUCOSE
Worthington Biochemical Corp.
CGA
Mar 30, 1977K770317GLUCOSE TRINDER, ENZYMATIC
Icn Pharmaceuticals, Inc.
CGA
Feb 23, 1977K770200GO/HPO-GLUCOSE REAGENT (TRINDER)
Beckman Instruments, Inc.
CGA
Feb 11, 1977K761148REFLOMAT/REFLOTEST SYSTEM
Boehringer Mannheim Corp.
CGA
Jan 25, 1977K761060GLUCOSE ANALYZER 2
Beckman Instruments, Inc.
CGA
Dec 13, 1976K761181GLUCOSE OXIDASE REAGENT SYSTEM
Nobel Scientific Industries, Inc.
CGA
Dec 9, 1976K761154GLUCOSE OXIDASE REAG FOR BECKMAN ANALYZ
Advanced Biomedical Methods, Inc.
CGA
Dec 9, 1976K761153GLUC OPAP, IN VITRO DIAG. FOR GLUCOSE
Advanced Biomedical Methods, Inc.
CGA

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