510(k) K843824

COBAS FP REAGENTS FOR PHENYTOIN & CALIBR by Roche Diagnostic Systems, Inc. — Product Code LGR

K843824 is an FDA 510(k) premarket notification submitted by Roche Diagnostic Systems, Inc. for the device "COBAS FP REAGENTS FOR PHENYTOIN & CALIBR". The FDA issued a decision of Substantially Equivalent on February 1, 1985. The device falls under product code LGR (Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total)), a Class II device regulated under 21 CFR 862.3350. Roche Diagnostic Systems, Inc. has at least 10 other 510(k) clearances on record.