Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides

FDA product code CDT · 150 cleared devices

Class 1 Clinical Chemistry

Regulation: 21 CFR 862.1705
Review panel: CH
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1976-07-26 – 2013-11-22

CDT 1983-08-31

ENZYMATIC TRIGLYCERIDES #2000

Applicant Stanbio Laboratory

K number K832444

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CDT 1983-07-22

TRIGLYCERIDES REAGENT SET

Applicant Stanbio Laboratory

K number K831858

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CDT 1983-02-25

TRIGLYCERIDE DIAGNOSTIC KIT

Applicant Sclavo, Inc.

K number K830288

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CDT 1983-01-07

TRIGLYCERIDE REAGENT (UV)

Applicant Gilford Diagnostics

K number K823709

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CDT 1982-12-22

TRIGLYCERIDES REAGENT SET TAG-GK

Applicant Sterling Biochemical, Inc.

K number K823341

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CDT 1982-07-20

TRIGLYCERIDE REAGENT SET

Applicant Omega Medical Electronics

K number K821205

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CDT 1982-07-13

ULTRACHEM TRI-ES

Applicant Harleco Diagnostics

K number K821875

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CDT 1982-05-24

DOWFLOW ENZYMATIC TRIGLYCERIDES DETERM

Applicant The Dow Chemical Co.

K number K821315

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CDT 1981-12-03

TRIGLYCERIDE REAGENT SET

Applicant Anco Medical Reagents & Assoc.

K number K812838

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CDT 1981-09-24

ULTRA CHEM E-TRIG #65024

Applicant Harleco

K number K812589

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CDT 1981-09-14

SPIN-CHEM TRIGLYCERIDES REAGENT

Applicant Smithkline Diagnostics, Inc.

K number K812471

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CDT 1981-08-03

KODAK EKTACHEM CLIN. CHEM. SLIDES (TRIG)

Applicant Eastman Kodak Company

K number K812029

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CDT 1981-07-23

ESKAFLOW TEST FOR TRIGLYCERIDES

Applicant Smithkline Diagnostics, Inc.

K number K811850

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CDT 1981-04-17

DATA-ZYME TRIGLYCERIDE

Applicant Data Medical Associates, Inc.

K number K810965

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CDT 1981-03-31

ENZYMATIC TRIGLYCERIDE

Applicant Pointe Scientific, Inc.,

K number K810680

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CDT 1981-01-16

LUQUIZYME TRIGLYCERIDE REAGENT SET

Applicant Amresco, Inc.

K number K803297

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CDT 1981-01-09

TRIGLYCERIDES (UV)-2 REAGENTS

Applicant Reagents Applications, Inc.

K number K803091

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CDT 1980-10-23

TRIGLYCERIDES DETERMINATION

Applicant Coleman Laboratories Corp.

K number K802256

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CDT 1980-10-10

DELTA TEST TRIGLYCERIDES

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K802136

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CDT 1980-09-16

WAKO TRIGLYCERIDE-G TEST

Applicant Wako Pure Chemical Industries, Ltd.

K number K801891

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CDT 1980-07-08

COBAS REAGENT FOR TRIGLYCERIDES & COBAS

Applicant Roche Analytical Instruments, Inc.

K number K801298

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CDT 1980-06-20

TRIGLYCERIDES FOR SMA AND AAII

Applicant Reagents Applications, Inc.

K number K801226

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CDT 1980-05-08

ENZYMATIC TRIGLYCERIDES REAFENT FOR SMAC

Applicant Reagents Applications, Inc.

K number K800649

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CDT 1980-03-05

SIGMA PROCEDURE & REAGENT SYSTEM #335-UV

Applicant Sigma Chemical Co.

K number K800301

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CDT 1979-12-27

CHEM-STRATE TRIGLYCERIDE

Applicant General Diagnostics

K number K792480

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CDT 1979-11-27

SINGLE VIAL COLORIMETRIC/TRIGLYCERIDES

Applicant Boehringer Mannheim Corp.

K number K792234

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CDT 1979-09-24

COULTER ACCU-ZYME II ENZYMATIC REAGENT

Applicant Coulter Electronics, Inc.

K number K791640

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CDT 1979-09-17

WAKO TRIGLYCERIDE

Applicant Wako Pure Chemical Industries, Ltd.

K number K791597

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CDT 1979-06-15

ENZYMATIC TRIGLYCERIDES-S.V.R.

Applicant Calbiochem-Behring Corp.

K number K790773

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CDT 1979-01-10

REAGENT KIT, TRIGLYCERIDES

Applicant Beckman Instruments, Inc.

K number K781939

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CDT 1978-10-03

TRIGLYCERIDES TEST KIT

Applicant Mallinckrodt Critical Care

K number K781477

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CDT 1978-10-03

AUTOMATED ENZYMATIC TRIGLYCERIDE REAGENT

Applicant Fisher Scientific Co., LLC

K number K781466

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CDT 1978-08-17

ENZYMATIC TRIGLYCERIDES REAGENT KIT

Applicant J.T. Baker Chemical Co.

K number K781240

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CDT 1978-05-12

DATA-ZYME TRIGLYCERIDE PROCEDURE

Applicant Data Medical Associates, Inc.

K number K780379

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CDT 1978-03-09

TRIGLYCERIDE INSTRUMENT APPLICATION

Applicant Harleco

K number K780172

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CDT 1977-12-06

PHOSPHATE

Applicant Simmler & Son, Inc.

K number K771906

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CDT 1977-12-06

GLYCEROL SUBSTRATE

Applicant Simmler & Son, Inc.

K number K771905

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CDT 1977-12-06

GLYCEROL KINASE

Applicant Simmler & Son, Inc.

K number K771904

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CDT 1977-12-06

LIPASE

Applicant Simmler & Son, Inc.

K number K771903

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CDT 1977-09-15

A-GENT TRIGLYCERIDES

Applicant Abbott Laboratories

K number K771608

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CDT 1977-09-12

AMHS BLOOD ANALY. TRIGLYCEOIDES REAG. KI

Applicant Miles Laboratories, Inc.

K number K771004

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CDT 1977-09-02

MULTISTAT III TRIGLYCERIDE TEST

Applicant Instrumentation Laboratory CO

K number K771472

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CDT 1977-09-02

TRIGLYCERIDE REAGENT SET

Applicant Macomb Chemical Co.

K number K770993

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CDT 1977-07-14

TRIGLYCERIDE ENZYMATIC METHOD

Applicant Union Carbide Corp.

K number K770841

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CDT 1976-12-29

TRIGLYCERIDES (LIPASE) REAGENT SET

Applicant Worthington Biochemical Corp.

K number K761262

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CDT 1976-12-21

ENZYMATIC TRIGLYCERIDES (END POINT)

Applicant Beckman Instruments, Inc.

K number K761200

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CDT 1976-11-29

TRIGLYCERIDES TEST

Applicant Boehringer Mannheim Corp.

K number K760713

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CDT 1976-09-15

ENZYMATIC TRIGLYCERIDE

Applicant Harleco

K number K760029

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CDT 1976-08-03

REAGENT, TRIGLY. C-ZYME NDC#12739-0017-1

Applicant Coulter Electronics, Inc.

K number K760195

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CDT 1976-07-26

REAGENT, TRIGLYCERIDES

Applicant The Dow Chemical Co.

K number K760011

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