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 Beckman Instruments, Inc..

151
Total
151
Cleared
62d
Avg days
1976
Since

FDA 510(k) Cleared Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides Devices (Product Code CDT)

151 devices
1–24 of 151
Cleared Jan 18, 2005
DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULE
K043546
Dade Behring, Inc.
Chemistry · 26d
Cleared Jul 09, 2001
TGL FLEX REAGENT CARTRIDGE
K010871
Dade Behring, Inc.
Chemistry · 108d
Cleared Aug 25, 1993
TRIGLYCERIDES
K931891
Em Diagnostic Systems, Inc.
Chemistry · 132d
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 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 Mar 11, 1991
SYSTEMATE TRIGLYCERIIDES (EPOS APPLICATION) #65477
K910638
Em Diagnostic Systems, Inc.
Chemistry · 26d
Cleared Feb 16, 1990
COBAS READY TRIGLYCERIDE REAGENT
K896231
Roche Diagnostic Systems, Inc.
Chemistry · 109d
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 Jan 21, 1988
A-GENT TRIGLLYCERIDES GPO
K874187
Abbott Laboratories
Chemistry · 99d
Cleared Aug 28, 1987
TRIGLYCERIDES GPO WITHOUT FREE GLYCEROL
K873049
Boehringer Mannheim Corp.
Chemistry · 24d
Cleared Mar 04, 1987
EASY-TEST TRIGLYCERIDE (TRIG) NUMBER 16608
K870408
Em Diagnostic Systems, Inc.
Chemistry · 29d
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 Aug 19, 1986
EMDS(TM) TRIGLYCERIDE TESTPACKS #67674/95
K862706
Em Diagnostic Systems, Inc.
Chemistry · 34d
Cleared Jun 27, 1986
TWIN TRIGLYCERIDES GPO/CHOLESTEROL
K861793
Boehringer Mannheim Corp.
Chemistry · 49d
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 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

About Product Code CDT - Regulatory Context