FDA 510(k) Applications for Medical Device Product Code "LCQ"
(Fluorescent Immunoassay Gentamicin)

FDA 510(k) Number Applicant Device Name Decision Date
K972609 BIO-RAD VARIANT EXPRESS GLYCOHEMOGLOBIN PROGRAM 08/06/1997
K955569 OXIS INTL., INC. INNOFLUOR GENTAMICIN ASSAY SYSTEM 02/09/1996


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