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Hexokinase, Glucose

FDA product code CFR · 144 cleared devices

Class 2 Clinical Chemistry

Regulation: 21 CFR 862.1345
Review panel: CH
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1976-08-26 – 2026-02-12

CFR 1985-09-30

GLUCOSE HEXOKINASE FOR CONTINUOUS FLOW INSTRUMENTS

Applicant Catachem, Inc.

K number K853826

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CFR 1985-09-04

GLUCOSE SR LIQUID STABLE REAGENT SET

Applicant Medical Analysis Systems, Inc.

K number K853464

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CFR 1985-01-18

GLUCOSE(HEXOKINASE) REAGENT SET

Applicant Sterling Biochemical, Inc.

K number K844998

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CFR 1984-09-28

PDA GLUCOSE

Applicant Abbott Laboratories

K number K843541

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CFR 1984-08-27

SYSTEMATE GLUCOSE 67216

Applicant Em Diagnostic Systems, Inc.

K number K843150

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CFR 1984-07-20

GLUCOSE ASSAY KIT-HEXOKINASE

Applicant Diagnostic Chemicals, Ltd. (Usa)

K number K842510

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CFR 1984-05-22

SIGMA PROCEDURE 16-UV

Applicant Sigma Chemical Co.

K number K841555

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CFR 1983-10-14

HEXOKINASE, GLUCOSE

Applicant Pointe Scientific, Inc.,

K number K832872

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CFR 1983-07-06

GLUCOSE HEXOKINASE DIAG. KIT

Applicant Sclavo, Inc.

K number K831560

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CFR 1982-07-08

ULTRACHEM E-GLU

Applicant Harleco Diagnostics

K number K821868

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CFR 1982-06-25

ULTRACHEM E-GLU #64976&65040

Applicant Emd Chemicals, Inc.

K number K821475

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CFR 1982-06-02

ULTRACHEM E-GLU #64976 & 65040

Applicant Emd Chemicals, Inc.

K number K821470

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CFR 1982-06-02

ULTRACHEM E-GLU, #64976 & 65040

Applicant Emd Chemicals, Inc.

K number K821461

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CFR 1981-09-29

ULTRA CHEM E-GLU #64976 & 65040

Applicant Harleco

K number K812595

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CFR 1981-09-01

GLUCOSE-HK SYSTEM PACK TEST

Applicant Boehringer Mannheim Corp.

K number K812303

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CFR 1981-07-15

ESKAFLOW TEST FOR GLUCOSE

Applicant Smithkline Diagnostics, Inc.

K number K811849

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CFR 1980-12-10

HEXOKINASE, GLUCOSE

Applicant Beckman Instruments, Inc.

K number K802810

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CFR 1980-10-03

F/LS MCA APPLICATION SOFTWARE

Applicant Instrumentation Laboratory CO

K number K801456

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CFR 1980-09-16

GLUCOSE REAGENT(UV-HEXOKINASE)

Applicant Reagents Applications, Inc.

K number K801765

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CFR 1980-06-30

COBAS REAGENT FOR GLUCOSE RAPID

Applicant Roche Analytical Instruments, Inc.

K number K801297

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CFR 1980-05-23

DATA-ZYME GLUCOSE HEXOKINASE UV

Applicant Data Medical Associates, Inc.

K number K801052

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CFR 1980-05-23

DATA-ZYME GLUCOSE HEXOKINASE COLOZIMETRI

Applicant Data Medical Associates, Inc.

K number K801051

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CFR 1980-01-11

GLUCOSE (HEXOKINASE) REAGENT SET

Applicant Macomb Chemical Co.

K number K792532

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CFR 1979-09-27

GLUCOSE HEXOKINASE COIL REAGENT SYSTEM

Applicant Fisher Scientific Co., LLC

K number K791760

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CFR 1979-06-15

GLUCOSE (HK) REAGENT

Applicant Gilford Diagnostics

K number K790786

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CFR 1979-01-26

GLUCOSE REAGENT SYSTEM

Applicant American Monitor Corp.

K number K782136

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CFR 1978-11-03

GLUCOSE HEXOKINASE, AUTO K

Applicant Medical Analysis Systems, Inc.

K number K781723

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CFR 1978-06-22

PRINCETON BIOMEDIX HEXOKINASE, GLUCOSE

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K780858

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CFR 1978-05-19

ULTRACHEM E-GLU, 300 SERIES CENTRIFUCHEM

Applicant Harleco

K number K780515

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CFR 1978-02-14

GLUCOSE REAGENT SET

Applicant Medical Analysis Systems, Inc.

K number K780072

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CFR 1978-02-01

ULTRACHEM E-GLU, MANUAL DETERM.

Applicant Harleco

K number K780065

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CFR 1977-09-02

MULTISTAT III GLUCOSE TEST

Applicant Instrumentation Laboratory CO

K number K771464

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CFR 1977-08-22

AUTOZYME IMMOBILIZED ENZYME COIL

Applicant Technicon Instruments Corp.

K number K771384

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CFR 1977-08-03

GLUCOSE REAGENT (HEXOHINASE)

Applicant Mallinckrodt Critical Care

K number K771311

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CFR 1977-07-14

AUTO-ENZYMATIC GLUCOSE FOR ANALYZER

Applicant Harleco

K number K770886

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CFR 1977-07-14

FLUCOSE U.V. TEST KIT

Applicant Mallinckrodt Critical Care

K number K770844

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CFR 1977-03-30

GLUCOSE REAGENT, ENZYMATIC

Applicant Icn Pharmaceuticals, Inc.

K number K770311

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CFR 1977-03-01

AUTO-ENZYMATIC GLUCOSE

Applicant Harleco

K number K770229

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CFR 1977-02-23

GLUCOSE (HEXOKINASE) DELTA TEST ASSAY

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K770262

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CFR 1977-01-25

GLUCOSE KIT

Applicant Environmental Chemical Specialties

K number K761320

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CFR 1977-01-05

GLUCO-HEX TM REAGENT KIT

Applicant J.T. Baker Chemical Co.

K number K761345

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CFR 1976-12-29

AUTO-ENZYMATIC GLUCOSE

Applicant Harleco

K number K761240

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CFR 1976-08-26

GLUCOSE REAGENT SYS, SIGMA PROCED. 115

Applicant Sigma Chemical Co.

K number K760247

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CFR 1976-08-26

REAGENT, GLUCOSE, FLOW-THROUGH ANALYZER

Applicant Smithkline Diagnostics, Inc.

K number K760055

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