ClearanceBrief
Panels › Clinical Chemistry › Product code CDT · Class 1

Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides

Regulation 862.1705

0510(k)s in 12 months (151 all time)
0recalls in 12 months (20 all time)
13recalls that name a 510(k)
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Top companies in CDT

Company510(k)sRecalls
Em Diagnostic Systems, Inc.130
Siemens Healthcare Diagnostics, Inc.18
Beckman Coulter Inc06
Boehringer Mannheim Corp.60
Data Medical Associates, Inc.60
Beckman Instruments, Inc.40
Randox Laboratories Limited22
Reagents Applications, Inc.40
Simmler & Son, Inc.40
Trace Scientific , Ltd.40
Decided510(k)Device and applicantCode
Aug 6, 2015K150819Triglycerides
Randox Laboratories Limited, GB
CDT
Nov 22, 2013K133067ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT
Siemens Healthcare Diagnostics, Inc.
CDT
May 31, 2013K130332VITROS CHEMISTRY PRODUCTS TRIG SLIDES
Ortho-Clinical Diagnostics, Inc.
CDT
Aug 30, 2012K113830VANTERA CLINICAL ANALYZER
Liposcience
CDT
May 19, 2011K102993ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL SYSTEMS CHOLESTEROL SL
Seppim S.A.S.
CDT
Mar 23, 2007K063804OLYMPUS TRIGLYCERIDE TEST SYSTEM
Olympus America, Inc.
CDT
Jan 18, 2005K043546DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULE
Dade Behring, Inc.
CDT
Mar 10, 2004K034000VITALAB TRIGLYCERIDES REAGENT AND VITALAB CALIBRATOR
Clinical Data, Inc.
CDT
Apr 15, 2002K020488CARESIDE TRGLYCERIDE
Careside, Inc.
CDT
Jul 9, 2001K010871TGL FLEX REAGENT CARTRIDGE
Dade Behring, Inc.
CDT
Nov 9, 1999K993466WAKO L-TYPE TRIGLYCERIDE TEST
Wako Chemicals USA, Inc.
CDT
Jun 20, 1997K971324TRIGLYCERIDES, TG, OR TRIG
Carolina Liquid Chemistries Corp.
CDT
May 29, 1997K971113DMA TRIGLYCERIDES PROCEDURES
Data Medical Associates, Inc.
CDT
Mar 28, 1997K964346PARAMAX TRIGLYCERID REAGENT
Dade Intl., Inc.
CDT
Jan 14, 1997K963424OLYMPUS LIPASE REAGENT
Olympus America, Inc.
CDT
Aug 16, 1996K961281TRIGLYCERIDE-SL ASSAY CATALOGUE NO. 236-60
Diagnostic Chemicals , Ltd., CA
CDT
Aug 5, 1996K961477TRIGLYCERIDES - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY
Trace America, Inc.
CDT
Jun 13, 1996K933722HORIZON DIAGNOSTICS TRIGLYCERIDES-GPO REAGENT
Horizon Diagnostics, Inc.
CDT
Apr 5, 1996K953971TRIGLYCERIDES LIQUID STABLE INCORPORATING DYNAMIC STABILISATION TECHNOLOGY
Trace America, Inc.
CDT
Apr 1, 1996K960088TRUE TRIGLYCERIDE
Diagnostic Chemicals , Ltd., CA
CDT
Aug 17, 1995K952741TRIGLYCERIDES (GLYCEROL BLANKING) REAGENT SYSTEM
Medical Diagnostic Technologies, Inc.
CDT
Nov 22, 1994K942998TRIGLYCERODES QVET
Prisma Systems
CDT
Aug 25, 1993K931891TRIGLYCERIDES
Em Diagnostic Systems, Inc.
CDT
Jul 28, 1993K923508TRIGLYCERIDES GPO-PAP
Randox Laboratories, Ltd., IR
CDT
Jan 26, 1993K924710TRIGLYCERIDES
Em Diagnostic Systems, Inc.
CDT
Nov 6, 1992K924573SYSTEMATE PLUS TRIGLYCERIDE-GLYCEROL BLANKED TEST
Em Diagnostic Systems, Inc.
CDT
Oct 28, 1992K924694LIPASE HYDROLYSIS/GLYCEROT KINASE ENZYME, TRIGLYC
Olympus Corp.
CDT
Aug 18, 1992K922964KING DIAGNOSTIC TRIGLYCERIDES REAGENT
King Diagnostics, Inc.
CDT
Jul 2, 1992K922229OLYMPUS TRIGLYCERIDE REAGENT
Olympus Corp.
CDT
Jan 28, 1992K915084BECKMAN SYCHRON(TM) TRIGLYCERIDES REAGENT
Beckman Instruments, Inc.
CDT
Jan 15, 1992K915732ABBOTT QUICKSTART TIGLYCERIDES REAGENT
Em Diagnostic Systems, Inc.
CDT
Nov 22, 1991K914018ABBOTT QUICKSTART TRIGLYCERIDES REAGENTS, #5A33
Em Diagnostic Systems, Inc.
CDT
Nov 7, 1991K914609TRIGLYCERIDES REAGENT SET
Sterling Diagnostics, Inc.
CDT
Mar 11, 1991K910638SYSTEMATE TRIGLYCERIIDES (EPOS APPLICATION) #65477
Em Diagnostic Systems, Inc.
CDT
Jan 17, 1991K905601ECLIPSE ICA TRIGLYCERIDES
Biotope, Inc.
CDT
Oct 1, 1990K903897TRIGLYCERIDES REAGENT GPO 5 X CONC.
Trace Scientific , Ltd., AU
CDT
Jul 27, 1990K903016SYNERMED TRIGLYCERIDES REAGENT KIT
Synermed, Inc., CA
CDT
Mar 9, 1990K897159COULTER TRIGLYCERIDES GPO REAGENT
Coulter Electronics, Inc.
CDT
Feb 23, 1990K897169QUIKREAD(R) WHOLE BLOOD TRIGLYCERIDE TEST KIT
Photec Diagnostics, Inc.
CDT
Feb 16, 1990K896231COBAS READY TRIGLYCERIDE REAGENT
Roche Diagnostic Systems, Inc.
CDT
Jan 11, 1990K895952TRIGLYCERIDES TEST KIT
Elite Technology, Inc., CA
CDT
Sep 28, 1989K894310AMRESCO TRIGLYCERIDES REAGENTS (PRODUCTS 7730)
American Research Products Co.
CDT
Aug 28, 1989K893917EMDS TRIGLYCERIDE (TRIG), ITEM NUMBER 65421
Em Diagnostic Systems, Inc.
CDT
Aug 11, 1989K893973ROCHE REAGENT FOR TRIGLYCERIDES
Roche Diagnostic Systems, Inc.
CDT
Mar 9, 1989K890337TRIGLYCERIDES - GPO REAGENT
Alpkem Corp.
CDT
Feb 7, 1989K885266OLYMPUS TRIGLYCERIDES REAGENTS #SR1021
Em Diagnostic Systems, Inc.
CDT
Sep 13, 1988K883405TRIGLYCERIDES REAGENT (PRODUCT #88218)
Hichem Diagnostics
CDT
May 27, 1988K881702BIOTROL TRIGLYCERIDES ENZYMATIQUE UV H.P.
Biotrol, USA, Inc.
CDT
Mar 15, 1988K880628TRIGLYCERIDES (GPO-TRINDER)
Tech-Co, Inc.
CDT
Mar 15, 1988K880238TRIGLYCERIDE
Tech-Neal Scientific, Inc.
CDT

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