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
145–151 of 151
Cleared Jul 14, 1977
TRIGLYCERIDE ENZYMATIC METHOD
K770841
Union Carbide Corp.
Chemistry · 66d
Cleared Dec 29, 1976
TRIGLYCERIDES (LIPASE) REAGENT SET
K761262
Worthington Biochemical Corp.
Chemistry · 13d
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