FDA 510(k) Applications for Medical Device Product Code "CDT"
(Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides)

FDA 510(k) Number Applicant Device Name Decision Date
K020488 CARESIDE, INC. CARESIDE TRGLYCERIDE 04/15/2002
K971324 CAROLINA LIQUID CHEMISTRIES CORP. TRIGLYCERIDES, TG, OR TRIG 06/20/1997
K034000 CLINICAL DATA, INC. VITALAB TRIGLYCERIDES REAGENT AND VITALAB CALIBRATOR 03/10/2004
K043546 DADE BEHRING, INC. DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULE 01/18/2005
K010871 DADE BEHRING, INC. TGL FLEX REAGENT CARTRIDGE 07/09/2001
K964346 DADE INTL., INC. PARAMAX TRIGLYCERID REAGENT 03/28/1997
K971113 DATA MEDICAL ASSOCIATES, INC. DMA TRIGLYCERIDES PROCEDURES 05/29/1997
K961281 DIAGNOSTIC CHEMICALS LTD. TRIGLYCERIDE-SL ASSAY CATALOGUE NO. 236-60 08/16/1996
K960088 DIAGNOSTIC CHEMICALS LTD. TRUE TRIGLYCERIDE 04/01/1996
K933722 HORIZON DIAGNOSTICS, INC. HORIZON DIAGNOSTICS TRIGLYCERIDES-GPO REAGENT 06/13/1996
K113830 LIPOSCIENCE VANTERA CLINICAL ANALYZER 08/30/2012
K963424 OLYMPUS AMERICA, INC. OLYMPUS LIPASE REAGENT 01/14/1997
K063804 OLYMPUS AMERICA, INC. OLYMPUS TRIGLYCERIDE TEST SYSTEM 03/23/2007
K130332 Ortho-Clinical Diagnostics, Inc. VITROS CHEMISTRY PRODUCTS TRIG SLIDES 05/31/2013
K150819 Randox Laboratories Limited Triglycerides 08/06/2015
K102993 SEPPIM S.A.S. ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL SYSTEMS CHOLESTEROL SL 05/19/2011
K133067 SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT 11/22/2013
K961477 TRACE AMERICA, INC. TRIGLYCERIDES - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY 08/05/1996
K953971 TRACE AMERICA, INC. TRIGLYCERIDES LIQUID STABLE INCORPORATING DYNAMIC STABILISATION TECHNOLOGY 04/05/1996
K993466 WAKO CHEMICALS, USA, INC. WAKO L-TYPE TRIGLYCERIDE TEST 11/09/1999


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact