510(k) K936131

COBAS-FP REAGENT FOR PHENYTOIN AND COBA-FP PHENYTOIN CALIBRATORS by Roche Diagnostic Systems, Inc. — Product Code LGR

K936131 is an FDA 510(k) premarket notification submitted by Roche Diagnostic Systems, Inc. for the device "COBAS-FP REAGENT FOR PHENYTOIN AND COBA-FP PHENYTOIN CALIBRATORS". The FDA issued a decision of Substantially Equivalent on March 11, 1994. 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.