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CDT — Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides Class I

FDA Device Classification

Classification Details

Product Code
CDT
Device Class
Class I
Regulation Number
862.1705
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K150819randox laboratories limitedTriglyceridesAugust 6, 2015
K133067siemens healthcare diagnosticsADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENTNovember 22, 2013
K130332ortho-clinical diagnosticsVITROS CHEMISTRY PRODUCTS TRIG SLIDESMay 31, 2013
K113830liposcienceVANTERA CLINICAL ANALYZERAugust 30, 2012
K102993seppimELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL SYSTEMS CHOLESTEROL May 19, 2011
K063804olympus americaOLYMPUS TRIGLYCERIDE TEST SYSTEMMarch 23, 2007
K043546dade behringDIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULEJanuary 18, 2005
K034000clinical dataVITALAB TRIGLYCERIDES REAGENT AND VITALAB CALIBRATORMarch 10, 2004
K020488caresideCARESIDE TRGLYCERIDEApril 15, 2002
K010871dade behringTGL FLEX REAGENT CARTRIDGEJuly 9, 2001
K993466wako chemicals usaWAKO L-TYPE TRIGLYCERIDE TESTNovember 9, 1999
K971324carolina liquid chemistriesTRIGLYCERIDES, TG, OR TRIGJune 20, 1997
K971113data medical associatesDMA TRIGLYCERIDES PROCEDURESMay 29, 1997
K964346dade intlPARAMAX TRIGLYCERID REAGENTMarch 28, 1997
K963424olympus americaOLYMPUS LIPASE REAGENTJanuary 14, 1997
K961281diagnostic chemicalsTRIGLYCERIDE-SL ASSAY CATALOGUE NO. 236-60August 16, 1996
K961477trace americaTRIGLYCERIDES - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGYAugust 5, 1996
K933722horizon diagnosticsHORIZON DIAGNOSTICS TRIGLYCERIDES-GPO REAGENTJune 13, 1996
K953971trace americaTRIGLYCERIDES LIQUID STABLE INCORPORATING DYNAMIC STABILISATION TECHNOLOGYApril 5, 1996
K960088diagnostic chemicalsTRUE TRIGLYCERIDEApril 1, 1996