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

FDA 510(k) Number Applicant Device Name Decision Date
K963286 BECKMAN INSTRUMENTS, INC. IMMAGE IMMUNOCHEMISTRY SYSTEM HAPTOGLOBIN (HPT) REAGENT 10/07/1996
K972639 BOEHRINGER MANNHEIM CORP. TINA-QUANT HAPTOGLOBIN 01/09/1998
K964301 CRESTAT DIAGNOSTICS, INC. N-ASSAY TIA MULTI V-NL 07/14/1997
K993480 KAMIYA BIOMEDICAL CO. K-ASSAY HAPTOGLOBIN 11/24/1999


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