510(k) K872397

COBAS FP REAGENTS FOR PHENO & COBAS FP PHENO CALI. by Roche Diagnostic Systems, Inc. — Product Code LGQ

K872397 is an FDA 510(k) premarket notification submitted by Roche Diagnostic Systems, Inc. for the device "COBAS FP REAGENTS FOR PHENO & COBAS FP PHENO CALI.". The FDA issued a decision of Substantially Equivalent on July 21, 1987. The device falls under product code LGQ (Fluorescence Polarization Immunoassay, Phenobarbital), a Class II device regulated under 21 CFR 862.3660. Roche Diagnostic Systems, Inc. has at least 10 other 510(k) clearances on record.