FDA 510(k) Applications for Medical Device Product Code "LGS"
(Fluorescence Polarization Immunoassay, Theophylline)

FDA 510(k) Number Applicant Device Name Decision Date
K070810 BIOKIT S.A. ARCHITECT I THEOPHYLLINE REAGENTS AND CALIBRATORS (A-F) 06/08/2007
K955567 OXIS INTL., INC. INNOFLUOR THEOPHYLLINE ASSAY SYSTEM 01/24/1996


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