FDA 510(k) Applications for Medical Device Product Code "KLQ"
(Radioimmunoassay, Amikacin)

FDA 510(k) Number Applicant Device Name Decision Date
K955570 OXIS INTL., INC. INNOFLUOR AMIKACIN ASSAY SYSTEM 02/09/1996
K033884 RANDOX LABORATORIES, LTD. RANDOX AMIKACIN 06/09/2004
K052815 SERADYN INC. QMS AMIKACIN REAGENTS 11/01/2005


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