FDA 510(k) Applications for Medical Device Product Code "DAH"
(Gamma Globulin, Antigen, Antiserum, Control)

FDA 510(k) Number Applicant Device Name Decision Date
K854944 ABBOTT LABORATORIES TDX IMMUNOGLOBULIN M DIAGNOSTIC KIT 08/27/1986
K862184 DAKO CORP. DAKO ITA, IMMUNOGLOBULIN M (IGM) 08/19/1986
K901805 HELENA LABORATORIES REP(R) IMMUNOFIX 06/06/1990
K905149 HELENA LABORATORIES TITAN GEL 01/03/1991
K931247 HELENA LABORATORIES TITAN GEL IMMUNOFIX-9 CAT. NO. 3051 AND 3067 04/27/1993
K884074 ORION DIAGNOSTICA, INC. IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN G 10/27/1988
K883494 TECHNICON INSTRUMENTS CORP. TECHNICON DPA-1 IMMUNOGLOBULIN G 09/07/1988


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