FDA 510(k) Applications for Medical Device Product Code "KXS"
(Radioimmunoassay, Methaqualone)

FDA 510(k) Number Applicant Device Name Decision Date
K955676 BECKMAN INSTRUMENTS, INC. SYNCHRON SYSTEMS METHAQUALONE REAGENT 03/04/1996
K993986 SYVA CO. SYVA EMIT II PLUS METHAQUALONE ASSAY, MODEL 9Q029UL/9Q129UL 01/27/2000
K011164 SYVA CO., DADE BEHRING, INC. MODIFICATION TO THE EMIT II PLUS METHAQUALONE ASSAY, MODEL OSR9Q229 05/10/2001


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