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
49–72 of 151
Cleared Sep 08, 1987
BIOTROL TRIGLYCERIDES ENZYMATIQUE COLOR
K873160
Biotrol, USA, Inc.
Chemistry · 28d
Cleared Aug 28, 1987
TRIGLYCERIDES GPO WITHOUT FREE GLYCEROL
K873049
Boehringer Mannheim Corp.
Chemistry · 24d
Cleared May 08, 1987
RESUBMITTED TRIGLYCERIDE GPO - TWO VIAL
K871508
Trace Scientific , Ltd.
Chemistry · 22d
Cleared May 08, 1987
RESUBMITTED TRIGLYCERIDE GPO REAGENT (SINGLE VIAL)
K871509
Trace Scientific , Ltd.
Chemistry · 22d
Cleared Apr 22, 1987
ENZYMATIC TRIGLYCERIDES GPO-TRINDER METHOD
K871301
American Monitor Corp.
Chemistry · 21d
Cleared Apr 07, 1987
TRIGLYCERIDES DETERMINATION
K871122
Biochemical Trade, Inc.
Chemistry · 18d
Cleared Mar 13, 1987
INTERSECT SYSTEMS TRIGLYCERIDE-GPO REAGENT
K870827
Intersect Systems, Inc.
Chemistry · 10d
Cleared Mar 04, 1987
EASY-TEST TRIGLYCERIDE (TRIG) NUMBER 16608
K870408
Em Diagnostic Systems, Inc.
Chemistry · 29d
Cleared Feb 20, 1987
TRIGLYCERIDE (GPO-TRINDER) REAGENT
K870012
Sigma Diagnostics, Inc.
Chemistry · 49d
Cleared Dec 31, 1986
BECKMAN DRI-STAT TRIGLYCERIDES-GPO REAGENT KIT
K864939
Beckman Instruments, Inc.
Chemistry · 15d
Cleared Dec 16, 1986
IQ TRIGLYCERIDES
K864268
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 48d
Cleared Dec 04, 1986
U.S. DIAGNOSTICS ENZYMATIC TRIGLYCERIDE TEST
K864231
U. S. Diagnostics, Inc.
Chemistry · 37d
Cleared Nov 24, 1986
TRIGLYCERIDES
K863923
Tech-Co, Inc.
Chemistry · 47d
Cleared Nov 13, 1986
LIPASE HYDROLYSIS/GLYCEROL KINASE, TRIGLYCERIDES
K863874
Electro-Nucleonics Laboratories, Inc.
Chemistry · 41d
Cleared Sep 26, 1986
TRIGLYCERIDES-E
K863075
J. D. Assoc.
Chemistry · 45d
Cleared Sep 26, 1986
TRIGLYCERIDE (TRINDER) PROCEDURE
K863254
Data Medical Associates, Inc.
Chemistry · 32d
Cleared Aug 19, 1986
EMDS(TM) TRIGLYCERIDE TESTPACKS #67674/95
K862706
Em Diagnostic Systems, Inc.
Chemistry · 34d
Cleared Jul 22, 1986
TRIGLYCERIDES
K862033
Pointe Scientific, Inc.,
Chemistry · 55d
Cleared Jul 01, 1986
TRIGLYCERIDE (TRINDER) PROCEDURE
K861670
Data Medical Associates, Inc.
Chemistry · 62d
Cleared Jun 27, 1986
TRIGLYCERIDES GPO-TRINDER
K861635
Catachem, Inc.
Chemistry · 59d
Cleared Jun 27, 1986
TWIN TRIGLYCERIDES GPO/CHOLESTEROL
K861793
Boehringer Mannheim Corp.
Chemistry · 49d
Cleared Apr 07, 1986
ENZYMATIC TRIGLYCERIDES REAGENT (SINGLE VIAL)
K860730
Trace Scientific , Ltd.
Chemistry · 40d
Cleared Mar 17, 1986
TRIGLYCERIDES FOR CONTINUOUS FLOW INSTRUMENTS
K860690
Catachem, Inc.
Chemistry · 20d
Cleared Feb 19, 1986
ENZYNATIC TRIGLYCERIDES REAGENT SET
K855164
Sterling Diagnostics, Inc.
Chemistry · 55d