FDA 510(k) Applications for Medical Device Product Code "LKL"
(Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control)

FDA 510(k) Number Applicant Device Name Decision Date
K964257 BECKMAN INSTRUMENTS, INC. IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ACID GLYCOPROTEIN (AAG) REAGENT 03/24/1997
K964299 CRESTAT DIAGNOSTICS, INC. N-ASSAY TIA MULTI V-NL 07/14/1997
K993441 KAMIYA BIOMEDICAL CO. K-ASSAY ALPHA-1 AG 11/24/1999


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