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 Aug 06, 2015
Triglycerides
K150819
Randox Laboratories Limited
Chemistry · 132d
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 Aug 30, 2012
VANTERA CLINICAL ANALYZER
K113830
Liposcience
Chemistry · 247d
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 Apr 15, 2002
CARESIDE TRGLYCERIDE
K020488
Careside, Inc.
Chemistry · 61d
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 Jun 20, 1997
TRIGLYCERIDES, TG, OR TRIG
K971324
Carolina Liquid Chemistries Corp.
Chemistry · 71d
Cleared May 29, 1997
DMA TRIGLYCERIDES PROCEDURES
K971113
Data Medical Associates, Inc.
Chemistry · 63d
Cleared Mar 28, 1997
PARAMAX TRIGLYCERID REAGENT
K964346
Dade Intl., Inc.
Chemistry · 148d
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 Aug 05, 1996
TRIGLYCERIDES - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY
K961477
Trace America, Inc.
Chemistry · 109d
Cleared Jun 13, 1996
HORIZON DIAGNOSTICS TRIGLYCERIDES-GPO REAGENT
K933722
Horizon Diagnostics, Inc.
Chemistry · 1046d
Cleared Apr 05, 1996
TRIGLYCERIDES LIQUID STABLE INCORPORATING DYNAMIC STABILISATION TECHNOLOGY
K953971
Trace America, Inc.
Chemistry · 226d
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 Nov 22, 1994
TRIGLYCERODES QVET
K942998
Prisma Systems
Chemistry · 152d
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

About Product Code CDT - Regulatory Context