FDA 510(k) Applications for Medical Device Product Code "JHM"
(Colorimetric Method, Lipoproteins)

FDA 510(k) Number Applicant Device Name Decision Date
K120662 ABAXIS, INC. PICCOLO HDL-CAPILLARY TEST SYSTEM 04/24/2012
K073072 DADE BEHRING, INC. DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B 02/21/2008
K032798 DADE BEHRING, INC. DIMENSION AUTOMATED HDL CHOLESTEROL (AHDL) FLEX REAGENT CARTRIDGE (DF48A) CATALOG # DF48A 10/30/2003
K983849 DADE BEHRING, INC. DIMENSION AUTOMATED HIGH DENSITY LIPOPROTEIN CHOLESTEROL (ADHL) FLEX REAGENT CARTRIDGE 01/11/1999
K022519 JAS Diagnostics, Inc. LDL CHOLESTEROL (AUTOMATED) 09/30/2002
K081300 SIEMENS HEALTHCARE DIAGNOSTICS DIMENSION VISTA HDLC FLEX REAGENT CARTRIDGE 07/02/2008


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