CDT · Class I · 21 CFR 862.1705

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

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

151
Total
151
Cleared
62d
Avg days
1976
Since
151 devices
73–96 of 151
Cleared Jan 22, 1986
TRIGLYCERIDE'S TEST (TRIGLI-CINET)
K854783
Sclavo, Inc.
Chemistry · 54d
Cleared Nov 25, 1985
IN-VITRO TEST DETERMINATION OF TRIALYCERIDE
K854182
Clinical Data, Inc.
Chemistry · 41d
Cleared Nov 25, 1985
ENZYMATIC TRIGLYCERIDES GPO-GRINDER METHOD
K854366
American Monitor Corp.
Chemistry · 27d
Cleared Nov 05, 1985
TECHNICON RA SYSTEMS FOR TRIGLYCERIDES ANALYSIS IN
K854152
Technicon Instruments Corp.
Chemistry · 25d
Cleared May 30, 1985
TGL REAGENT
K852010
Alpkem Corp.
Chemistry · 23d
Cleared May 20, 1985
TRIGLYCERIDE(TRINDER) PROCEDURE
K851538
Data Medical Associates, Inc.
Chemistry · 34d
Cleared Mar 11, 1985
PERIDOCHROM TRIGLYCERIDES GPO
K850667
Boehringer Mannheim Corp.
Chemistry · 19d
Cleared Feb 04, 1985
VISION TRIGLYCERIDES
K850031
Abbott Laboratories
Chemistry · 28d
Cleared Nov 09, 1984
TRIGLYCERIDE REAGENT
K844032
Sigma Diagnostics, Inc.
Chemistry · 25d
Cleared Oct 11, 1984
TRIGLYCERIDE ASSAY KIT GPO-CP
K843536
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 34d
Cleared Sep 26, 1984
TRIGLYCERIDES GPO REAGENT
K843552
Bio-Rad
Chemistry · 16d
Cleared Aug 27, 1984
SYSTEMATE TRIGLYCERIDE 67219
K843106
Em Diagnostic Systems, Inc.
Chemistry · 20d
Cleared Aug 22, 1984
QCA TRIGLYCERIDES
K842891
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 30d
Cleared Jul 09, 1984
TRIGLYCERIDES-GPO REAGENT
K842029
Reagents Applications, Inc.
Chemistry · 52d
Cleared Jul 06, 1984
ULTRA CHEM ENZYMATIC TRIGLYCERIDE
K842211
Em Diagnostic Systems, Inc.
Chemistry · 32d
Cleared May 16, 1984
ULTRA CHEM ENZYMATIC TRIGLYCERIDE
K841471
Em Diagnostic Systems, Inc.
Chemistry · 37d
Cleared May 01, 1984
TRIGLYCERIDE REAGENT SET
K841062
Medical Specialties, Inc.
Chemistry · 50d
Cleared Apr 05, 1984
TRIGLYCERIDES REAGENT
K840780
American Dade
Chemistry · 57d
Cleared Mar 02, 1984
LIQUID STABLE TRIGLYCERIDES REAGENT SET
K834518
Medical Analysis Systems, Inc.
Chemistry · 72d
Cleared Nov 25, 1983
REAGENT SET TRIGLYCERIDES GPO
K833082
Boehringer Mannheim Corp.
Chemistry · 74d
Cleared Oct 14, 1983
LIPASE HYDROLYSIS/GLYCEROL KINASE
K832871
Pointe Scientific, Inc.,
Chemistry · 50d
Cleared Oct 04, 1983
SERALYZER TRIGLYCERIDES REAGENT STRIPS
K832684
Miles Laboratories, Inc.
Chemistry · 56d
Cleared Sep 12, 1983
EASYTOUCH TRIGLYCERIDES REAGENT SET
K832426
Worthington Diagnostic Systems
Chemistry · 52d
Cleared Aug 31, 1983
ENZYMATIC TRIGLYCERIDES #2000
K832444
Stanbio Laboratory
Chemistry · 37d