510(k) K871680

MODIFIED COBAS FP REAGENTS FOR NAPA AND CALIBRATOR by Roche Diagnostic Systems, Inc. — Product Code LAN

K871680 is an FDA 510(k) premarket notification submitted by Roche Diagnostic Systems, Inc. for the device "MODIFIED COBAS FP REAGENTS FOR NAPA AND CALIBRATOR". The FDA issued a decision of Substantially Equivalent on June 8, 1987. The device falls under product code LAN (Enzyme Immunoassay, N-Acetylprocainamide), a Class II device regulated under 21 CFR 862.3320. Roche Diagnostic Systems, Inc. has at least 10 other 510(k) clearances on record.