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JHM — Colorimetric Method, Lipoproteins Class I

FDA Device Classification

Classification Details

Product Code
JHM
Device Class
Class I
Regulation Number
862.1475
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K120662abaxisPICCOLO HDL-CAPILLARY TEST SYSTEMApril 24, 2012
K081300siemens healthcare diagnosticsDIMENSION VISTA HDLC FLEX REAGENT CARTRIDGEJuly 2, 2008
K073072dade behringDIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48BFebruary 21, 2008
K032798dade behringDIMENSION AUTOMATED HDL CHOLESTEROL (AHDL) FLEX REAGENT CARTRIDGE (DF48A) CATALOOctober 30, 2003
K022519jas diagnosticsLDL CHOLESTEROL (AUTOMATED)September 30, 2002
K983849dade behringDIMENSION AUTOMATED HIGH DENSITY LIPOPROTEIN CHOLESTEROL (ADHL) FLEX REAGENT CARJanuary 11, 1999
K902935roche diagnostic systemsROCHE COBAS READY HDL CHOLESTEROL REAGENTSeptember 27, 1990
K841056medical specialtiesHDL PRECIPITANT REAGENT SETMay 1, 1984
K780173environmental chemical specialtiesLYPOPROTEIN CHOLESTEROL TEST KITMay 3, 1978