510(k) K870277

MONITORX LASERX THEOPHYLLINE REAGENT SET by American Monitor Corp. — Product Code LGS

K870277 is an FDA 510(k) premarket notification submitted by American Monitor Corp. for the device "MONITORX LASERX THEOPHYLLINE REAGENT SET". The FDA issued a decision of Substantially Equivalent on February 18, 1987. The device falls under product code LGS (Fluorescence Polarization Immunoassay, Theophylline), a Class II device regulated under 21 CFR 862.3880. American Monitor Corp. has at least 10 other 510(k) clearances on record.