FDA 510(k) Applications for Medical Device Product Code "CHN"
(Immunochemical, Ceruloplasmin)

FDA 510(k) Number Applicant Device Name Decision Date
K063655 DADE BEHRING, INC. DIMENSION VISTA; CER FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, PROTEIN 1 CONTROL HIGH 02/15/2007
K091741 Roche Diagnostics TINA-QUANT CERULOPLASMIN 03/18/2010
K062114 ROCHE DIAGNOSTICS CORP. CERULOPLASMIN, MODEL 2055953 01/31/2007


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