510(k) K952555

COBAS-FP APPLICATION FOR FREE PHENYTOIN, COBAS-FP PHENYTOIN CALIBRATORS, & CONTROLS by Roche Diagnostic Systems, Inc. — Product Code MOJ

K952555 is an FDA 510(k) premarket notification submitted by Roche Diagnostic Systems, Inc. for the device "COBAS-FP APPLICATION FOR FREE PHENYTOIN, COBAS-FP PHENYTOIN CALIBRATORS, & CONTROLS". The FDA issued a decision of Substantially Equivalent on July 31, 1995. The device falls under product code MOJ (Fluorescence Polarization Immunoassay, Diphenylhydantoin (Free)), a Class II device regulated under 21 CFR 862.3350. Roche Diagnostic Systems, Inc. has at least 10 other 510(k) clearances on record.