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510(k) K923508

Device
TRIGLYCERIDES GPO-PAP
Applicant
RANDOX LABORATORIES, LTD.
510(k) number
K923508
Product code
CDT  
Decision
Substantially Equivalent (SESE)
Decision date
1993-07-28
Date received
1992-07-15
Regulation
862.1705
Classification name
Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
JOH LAMONT
Address
Ardmore, Diamond Rd. Crumlin, Bt29 4qy Co. Antrim, N. Ireland IR

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code CDT  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K150819TriglyceridesRandox Laboratories Limited2015-08-06
K133067ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENTSiemens Healthcare Diagnostics, Inc.2013-11-22
K130332VITROS CHEMISTRY PRODUCTS TRIG SLIDESOrtho-Clinical Diagnostics, Inc.2013-05-31
K113830VANTERA CLINICAL ANALYZERLiposcience2012-08-30
K102993ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL SYSTEMS CHOLESTEROL SLSeppim S.A.S.2011-05-19
K063804OLYMPUS TRIGLYCERIDE TEST SYSTEMOlympus America, Inc.2007-03-23
K043546DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULEDade Behring, Inc.2005-01-18
K034000VITALAB TRIGLYCERIDES REAGENT AND VITALAB CALIBRATORClinical Data, Inc.2004-03-10
K020488CARESIDE TRGLYCERIDECareside, Inc.2002-04-15
K010871TGL FLEX REAGENT CARTRIDGEDade Behring, Inc.2001-07-09
K993466WAKO L-TYPE TRIGLYCERIDE TESTWako Chemicals USA, Inc.1999-11-09
K971324TRIGLYCERIDES, TG, OR TRIGCarolina Liquid Chemistries Corp.1997-06-20
K971113DMA TRIGLYCERIDES PROCEDURESData Medical Associates, Inc.1997-05-29
K964346PARAMAX TRIGLYCERID REAGENTDade Intl., Inc.1997-03-28
K963424OLYMPUS LIPASE REAGENTOlympus America, Inc.1997-01-14

Legacy Summary#

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FDA Review#

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