CDT · Class I · 21 CFR 862.1705

FDA Product Code CDT: Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides

Leading manufacturers include Em Diagnostic Systems, Inc., Data Medical Associates, Inc. and Boehringer Mannheim Corp..

151
Total
151
Cleared
62d
Avg days
1976
Since
151 devices
121–144 of 151
Cleared Sep 16, 1980
WAKO TRIGLYCERIDE-G TEST
K801891
Wako Pure Chemical Industries, Ltd.
Chemistry · 39d
Cleared Jul 08, 1980
COBAS REAGENT FOR TRIGLYCERIDES & COBAS
K801298
Roche Analytical Instruments, Inc.
Chemistry · 36d
Cleared Jun 20, 1980
TRIGLYCERIDES FOR SMA AND AAII
K801226
Reagents Applications, Inc.
Chemistry · 29d
Cleared May 08, 1980
ENZYMATIC TRIGLYCERIDES REAFENT FOR SMAC
K800649
Reagents Applications, Inc.
Chemistry · 45d
Cleared Mar 05, 1980
SIGMA PROCEDURE & REAGENT SYSTEM #335-UV
K800301
Sigma Chemical Co.
Chemistry · 23d
Cleared Dec 27, 1979
CHEM-STRATE TRIGLYCERIDE
K792480
General Diagnostics
Chemistry · 24d
Cleared Nov 27, 1979
SINGLE VIAL COLORIMETRIC/TRIGLYCERIDES
K792234
Boehringer Mannheim Corp.
Chemistry · 21d
Cleared Sep 24, 1979
COULTER ACCU-ZYME II ENZYMATIC REAGENT
K791640
Coulter Electronics, Inc.
Chemistry · 34d
Cleared Sep 17, 1979
WAKO TRIGLYCERIDE
K791597
Wako Pure Chemical Industries, Ltd.
Chemistry · 33d
Cleared Jun 15, 1979
ENZYMATIC TRIGLYCERIDES-S.V.R.
K790773
Calbiochem-Behring Corp.
Chemistry · 56d
Cleared Jan 10, 1979
REAGENT KIT, TRIGLYCERIDES
K781939
Beckman Instruments, Inc.
Chemistry · 51d
Cleared Oct 03, 1978
AUTOMATED ENZYMATIC TRIGLYCERIDE REAGENT
K781466
Fisher Scientific Co., LLC
Chemistry · 40d
Cleared Oct 03, 1978
TRIGLYCERIDES TEST KIT
K781477
Mallinckrodt Critical Care
Chemistry · 36d
Cleared Aug 17, 1978
ENZYMATIC TRIGLYCERIDES REAGENT KIT
K781240
J.T. Baker Chemical Co.
Chemistry · 28d
Cleared May 12, 1978
DATA-ZYME TRIGLYCERIDE PROCEDURE
K780379
Data Medical Associates, Inc.
Chemistry · 65d
Cleared Mar 09, 1978
TRIGLYCERIDE INSTRUMENT APPLICATION
K780172
Harleco
Chemistry · 35d
Cleared Dec 06, 1977
LIPASE
K771903
Simmler & Son, Inc.
Chemistry · 60d
Cleared Dec 06, 1977
GLYCEROL KINASE
K771904
Simmler & Son, Inc.
Chemistry · 60d
Cleared Dec 06, 1977
GLYCEROL SUBSTRATE
K771905
Simmler & Son, Inc.
Chemistry · 60d
Cleared Dec 06, 1977
PHOSPHATE
K771906
Simmler & Son, Inc.
Chemistry · 60d
Cleared Sep 15, 1977
A-GENT TRIGLYCERIDES
K771608
Abbott Laboratories
Chemistry · 24d
Cleared Sep 12, 1977
AMHS BLOOD ANALY. TRIGLYCEOIDES REAG. KI
K771004
Miles Laboratories, Inc.
Chemistry · 102d
Cleared Sep 02, 1977
TRIGLYCERIDE REAGENT SET
K770993
Macomb Chemical Co.
Chemistry · 93d
Cleared Sep 02, 1977
MULTISTAT III TRIGLYCERIDE TEST
K771472
Instrumentation Laboratory CO
Chemistry · 29d