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 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 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
Cleared Jul 14, 1977
TRIGLYCERIDE ENZYMATIC METHOD
K770841
Union Carbide Corp.
Chemistry · 66d
Cleared Dec 21, 1976
ENZYMATIC TRIGLYCERIDES (END POINT)
K761200
Beckman Instruments, Inc.
Chemistry · 15d
Cleared Nov 29, 1976
TRIGLYCERIDES TEST
K760713
Boehringer Mannheim Corp.
Chemistry · 66d
Cleared Sep 15, 1976
ENZYMATIC TRIGLYCERIDE
K760029
Harleco
Chemistry · 93d
Cleared Aug 03, 1976
REAGENT, TRIGLY. C-ZYME NDC#12739-0017-1
K760195
Coulter Electronics, Inc.
Chemistry · 28d
Cleared Jul 26, 1976
REAGENT, TRIGLYCERIDES
K760011
The Dow Chemical Co.
Chemistry · 46d