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JGY — Colorimetric Method, Triglycerides Class I

FDA Device Classification

Classification Details

Product Code
JGY
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
K120664abaxisPICCOLO TRGLYCERIDES-CAPILLARY TEST SYSTEMApril 24, 2012
K023639abaxisPICCOLO TRIGLYCERIDES TEST SYSTEMJanuary 24, 2003
K000586polymer technology systemsBIOSCANNER TRIGLYCERIDES TEST STRIPSJuly 3, 2000
K991894polymer technology systemsBIOSCANNER TRIGLYCERIDES TEST STRIPSMay 24, 2000
K971005derma media labTRIGLYCERIDESApril 21, 1997
K954187schiapparelli biosystemsTRIGLYCERIDES REAGENTOctober 23, 1995
K941063data medical associatesDNA TRIGLYCERIDE PROCEDUREJuly 20, 1994
K931116instrumentation laboratoryIL TEST(TM) TRIGLYCERIDEMarch 28, 1994
K914033cholestechCHOLESTECH LIPID MONITOR SYST, TRIGLYCERIDES TESTSeptember 27, 1991
K905226enzyme technologyTRIGLYCERIDE (GPO) REAGENT, UNIVERSALDecember 11, 1990
K902202data medical associatesDMA TRIGLYCERIDE (GPO) PROCEDUREJuly 31, 1990
K894063sigma diagnosticsTRIGLYCERIDE (GPO) TRINDER REAGENTSeptember 7, 1989
K885134heraeus kulzerCLINISTAT TRIGLYCERIDES REAGENT TESTFebruary 10, 1989
K860731trace scientificTRIGLYCERIDES REAGENT (INT, COLORIMETRIC)April 7, 1986
K832460seppimTRIGLYCERIDE REAGENT-TRINDER-GPOSeptember 12, 1983
K821106syn-kitTRIGLYZYME V EIKENMay 5, 1982
K801012gilford diagnosticsTRIGLYCERIDE REAGENT (COLOR)May 14, 1980
K800551reagents applicationsTRIGLYCERIDES TEST (500NM)March 25, 1980
K792414volu sol medical industriesELVI TRIGLYCERIDEDecember 7, 1979
K791962worthington diagnostic systemsWORTHINGTON TRIGLYCERIDES REAGENT SETNovember 5, 1979