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
25–48 of 151
Cleared Jan 26, 1993
TRIGLYCERIDES
K924710
Em Diagnostic Systems, Inc.
Chemistry · 130d
Cleared Nov 06, 1992
SYSTEMATE PLUS TRIGLYCERIDE-GLYCEROL BLANKED TEST
K924573
Em Diagnostic Systems, Inc.
Chemistry · 57d
Cleared Oct 28, 1992
LIPASE HYDROLYSIS/GLYCEROT KINASE ENZYME, TRIGLYC
K924694
Olympus Corp.
Chemistry · 42d
Cleared Aug 18, 1992
KING DIAGNOSTIC TRIGLYCERIDES REAGENT
K922964
King Diagnostics, Inc.
Chemistry · 60d
Cleared Jul 02, 1992
OLYMPUS TRIGLYCERIDE REAGENT
K922229
Olympus Corp.
Chemistry · 51d
Cleared Jan 28, 1992
BECKMAN SYCHRON(TM) TRIGLYCERIDES REAGENT
K915084
Beckman Instruments, Inc.
Chemistry · 77d
Cleared Jan 15, 1992
ABBOTT QUICKSTART TIGLYCERIDES REAGENT
K915732
Em Diagnostic Systems, Inc.
Chemistry · 26d
Cleared Nov 22, 1991
ABBOTT QUICKSTART TRIGLYCERIDES REAGENTS, #5A33
K914018
Em Diagnostic Systems, Inc.
Chemistry · 74d
Cleared Nov 07, 1991
TRIGLYCERIDES REAGENT SET
K914609
Sterling Diagnostics, Inc.
Chemistry · 21d
Cleared Mar 11, 1991
SYSTEMATE TRIGLYCERIIDES (EPOS APPLICATION) #65477
K910638
Em Diagnostic Systems, Inc.
Chemistry · 26d
Cleared Jan 17, 1991
ECLIPSE ICA TRIGLYCERIDES
K905601
Biotope, Inc.
Chemistry · 35d
Cleared Oct 01, 1990
TRIGLYCERIDES REAGENT GPO 5 X CONC.
K903897
Trace Scientific , Ltd.
Chemistry · 39d
Cleared Jul 27, 1990
SYNERMED TRIGLYCERIDES REAGENT KIT
K903016
Synermed, Inc.
Chemistry · 17d
Cleared Mar 09, 1990
COULTER TRIGLYCERIDES GPO REAGENT
K897159
Coulter Electronics, Inc.
Chemistry · 71d
Cleared Feb 23, 1990
QUIKREAD(R) WHOLE BLOOD TRIGLYCERIDE TEST KIT
K897169
Photec Diagnostics, Inc.
Chemistry · 57d
Cleared Feb 16, 1990
COBAS READY TRIGLYCERIDE REAGENT
K896231
Roche Diagnostic Systems, Inc.
Chemistry · 109d
Cleared Jan 11, 1990
TRIGLYCERIDES TEST KIT
K895952
Elite Technology, Inc.
Chemistry · 92d
Cleared Sep 28, 1989
AMRESCO TRIGLYCERIDES REAGENTS (PRODUCTS 7730)
K894310
American Research Products Co.
Chemistry · 76d
Cleared Aug 28, 1989
EMDS TRIGLYCERIDE (TRIG), ITEM NUMBER 65421
K893917
Em Diagnostic Systems, Inc.
Chemistry · 90d
Cleared Aug 11, 1989
ROCHE REAGENT FOR TRIGLYCERIDES
K893973
Roche Diagnostic Systems, Inc.
Chemistry · 70d
Cleared Mar 09, 1989
TRIGLYCERIDES - GPO REAGENT
K890337
Alpkem Corp.
Chemistry · 45d
Cleared Feb 07, 1989
OLYMPUS TRIGLYCERIDES REAGENTS #SR1021
K885266
Em Diagnostic Systems, Inc.
Chemistry · 47d
Cleared Sep 13, 1988
TRIGLYCERIDES REAGENT (PRODUCT #88218)
K883405
Hichem Diagnostics
Chemistry · 33d
Cleared May 27, 1988
BIOTROL TRIGLYCERIDES ENZYMATIQUE UV H.P.
K881702
Biotrol, USA, Inc.
Chemistry · 38d