510(k) K936130

COBAS-FP REAGENT FOR PHENOBARBITAL AND COBAS-FP PHENOBARBITAL CALIBRATORS by Roche Diagnostic Systems, Inc. — Product Code LGQ

K936130 is an FDA 510(k) premarket notification submitted by Roche Diagnostic Systems, Inc. for the device "COBAS-FP REAGENT FOR PHENOBARBITAL AND COBAS-FP PHENOBARBITAL CALIBRATORS". The FDA issued a decision of Substantially Equivalent on March 11, 1994. 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.