510(k) K070810

ARCHITECT I THEOPHYLLINE REAGENTS AND CALIBRATORS (A-F) by Biokit, S.A. — Product Code LGS

K070810 is an FDA 510(k) premarket notification submitted by Biokit, S.A. for the device "ARCHITECT I THEOPHYLLINE REAGENTS AND CALIBRATORS (A-F)". The FDA issued a decision of Substantially Equivalent on June 8, 2007. The device falls under product code LGS (Fluorescence Polarization Immunoassay, Theophylline), a Class II device regulated under 21 CFR 862.3880. Biokit, S.A. has at least 10 other 510(k) clearances on record.