FDA 510(k) Applications for Medical Device Product Code "DAD"
(Haptoglobin, Antigen, Antiserum, Control)

FDA 510(k) Number Applicant Device Name Decision Date
K850584 APPLICATIONS LAB SPQ TEST SYSTEM FOR HAPTOGLOBIN 03/05/1985
K890562 ATLANTIC ANTIBODIES SPQ(TM) ANTIBODY REAGENT SET II FOR HPT 02/22/1989
K963286 BECKMAN INSTRUMENTS, INC. IMMAGE IMMUNOCHEMISTRY SYSTEM HAPTOGLOBIN (HPT) REAGENT 10/07/1996
K952593 BEHRING DIAGNOSTICS, INC. N/T PROTEIN CONTROL SY/L, M AND H 07/17/1995
K972639 BOEHRINGER MANNHEIM CORP. TINA-QUANT HAPTOGLOBIN 01/09/1998
K864512 COOPERBIOMEDICAL, INC. IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/HUMAN HAPTO 02/13/1987
K964301 CRESTAT DIAGNOSTICS, INC. N-ASSAY TIA MULTI V-NL 07/14/1997
K812494 DAKO CORP. IMMUNOGL. FRCT. OF RABBIT ANTISER.-HAPTO 09/23/1981
K915829 INSTRUMENTATION LABORATORY CO. IL TEST(TM) HAPTOGLOBIN (HPT) 07/29/1992
K801433 J.T. BAKER CHEMICAL CO. HAPTOGLOBIN NEPHELOMETRIC ASSAY 07/08/1980
K872717 KALLESTAD DIAG, A DIV. OF ERBAMONT, INC. QM300 HAPTOGLOBIN ANTIBODY PACK 07/21/1987
K772245 KALLESTAD LABORATORIES, INC. HAPTOGLOBIN NEPHELOMETRIC ASSAY 12/22/1977
K993480 KAMIYA BIOMEDICAL CO. K-ASSAY HAPTOGLOBIN 11/24/1999
K831957 KENT LABORATORIES, INC. DETERM. SIZE 72 RADIAL HUMAN HAPTOGLOB 07/18/1983
K760144 OXFORD LABORATORIES, INC. SERUM, HAPTOGLOBIN GOAT ANTI-HUMAN ACID 07/20/1976
K911898 REAGENTS APPLICATIONS, INC. RAICHEM(TM) SPIA(TM) HAPTOGLOBIN REAGENT 05/08/1991
K840404 TAGO, INC. DIFFU-GEN HAPTOGLOBIN RADIAL IMMUNO 03/09/1984
K873866 UNIPATH LTD. HAPTOGLOBIN 10/20/1987


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