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

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

151 devices
1–24 of 151
Cleared Nov 22, 2013
ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT
K133067
Siemens Healthcare Diagnostics, Inc.
Chemistry · 56d
Cleared May 31, 2013
VITROS CHEMISTRY PRODUCTS TRIG SLIDES
K130332
Ortho-Clinical Diagnostics, Inc.
Chemistry · 109d
Cleared Mar 23, 2007
OLYMPUS TRIGLYCERIDE TEST SYSTEM
K063804
Olympus America, Inc.
Chemistry · 91d
Cleared Jan 18, 2005
DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULE
K043546
Dade Behring, Inc.
Chemistry · 26d
Cleared Mar 10, 2004
VITALAB TRIGLYCERIDES REAGENT AND VITALAB CALIBRATOR
K034000
Clinical Data, Inc.
Chemistry · 77d
Cleared Jul 09, 2001
TGL FLEX REAGENT CARTRIDGE
K010871
Dade Behring, Inc.
Chemistry · 108d
Cleared Nov 09, 1999
WAKO L-TYPE TRIGLYCERIDE TEST
K993466
Wako Chemicals USA, Inc.
Chemistry · 27d
Cleared May 29, 1997
DMA TRIGLYCERIDES PROCEDURES
K971113
Data Medical Associates, Inc.
Chemistry · 63d
Cleared Jan 14, 1997
OLYMPUS LIPASE REAGENT
K963424
Olympus America, Inc.
Chemistry · 137d
Cleared Aug 16, 1996
TRIGLYCERIDE-SL ASSAY CATALOGUE NO. 236-60
K961281
Diagnostic Chemicals , Ltd.
Chemistry · 135d
Cleared Apr 01, 1996
TRUE TRIGLYCERIDE
K960088
Diagnostic Chemicals , Ltd.
Chemistry · 81d
Cleared Aug 17, 1995
TRIGLYCERIDES (GLYCEROL BLANKING) REAGENT SYSTEM
K952741
Medical Diagnostic Technologies, Inc.
Chemistry · 62d
Cleared Aug 25, 1993
TRIGLYCERIDES
K931891
Em Diagnostic Systems, Inc.
Chemistry · 132d
Cleared Jul 28, 1993
TRIGLYCERIDES GPO-PAP
K923508
Randox Laboratories, Ltd.
Chemistry · 378d
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

About Product Code CDT - Regulatory Context