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 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 16, 1990
COBAS READY TRIGLYCERIDE REAGENT
K896231
Roche Diagnostic Systems, Inc.
Chemistry · 109d
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 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
Cleared Mar 15, 1988
TRIGLYCERIDES (GPO-TRINDER)
K880628
Tech-Co, Inc.
Chemistry · 28d
Cleared Jan 21, 1988
A-GENT TRIGLLYCERIDES GPO
K874187
Abbott Laboratories
Chemistry · 99d
Cleared Jan 21, 1988
TRIGLYERIDES TEST KIT
K874584
Ciba Corning Diagnostics Corp.
Chemistry · 73d
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 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 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