FDA 510(k) Applications for Medical Device Product Code "DAS"
(Igg (Fc Fragment Specific), Antigen, Antiserum, Control)

FDA 510(k) Number Applicant Device Name Decision Date
K982023 INOVA DIAGNOSTICS, INC. PELICALSS HUMAN IGG SUBCLASS NEPHLOMETRIC ARRAY KIT 09/04/1998
K790715 KENT LABORATORIES, INC. ANTISERUM TO HUMAN FC 08/16/1979
K790708 KENT LABORATORIES, INC. ANTISERUM TO HUMAN IG G FC FRAGMENTS 08/22/1979
K943098 RESEARCH DIAGNOSTICS, INC. HUMAN IGG SUBCLASSES ELISA COMBI KIT 09/07/1994
K944876 RESEARCH DIAGNOSTICS, INC. HUMAN IGG SUBCLASSES NEPHELOMETRIC BNA KIT 12/15/1994
K943205 RESEARCH DIAGNOSTICS, INC. HUMAN IGG SUBCLASSES RID COMBI KIT (MODIFICATION) 09/07/1994
K761156 SUPELCO, INC. AMINOGLYCOSIDE CONTROLS 12/09/1976
K895600 THE BINDING SITE, LTD. HUMAN (IGG) SUBCLASS (EIA) KIT 11/08/1989


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