510(k) K945523

COBAS(R)-FP REAGENTS FOR GENTAMICIN AND COBAS(R)-FP GENTAMICIN CALIBRATORS by Roche Diagnostic Systems, Inc. — Product Code LCQ

K945523 is an FDA 510(k) premarket notification submitted by Roche Diagnostic Systems, Inc. for the device "COBAS(R)-FP REAGENTS FOR GENTAMICIN AND COBAS(R)-FP GENTAMICIN CALIBRATORS". The FDA issued a decision of Substantially Equivalent on March 9, 1995. The device falls under product code LCQ (Fluorescent Immunoassay Gentamicin), a Class II device regulated under 21 CFR 862.3450. Roche Diagnostic Systems, Inc. has at least 10 other 510(k) clearances on record.