510(k) K982848

COBAS INTEGRA LDL DIRECT REAGENT CASSETTE ROCHE CALIBRATOR LDL DIRECT by Roche Diagnostic Systems, Inc. — Product Code MRR

K982848 is an FDA 510(k) premarket notification submitted by Roche Diagnostic Systems, Inc. for the device "COBAS INTEGRA LDL DIRECT REAGENT CASSETTE ROCHE CALIBRATOR LDL DIRECT". The FDA issued a decision of Substantially Equivalent on October 1, 1998. The device falls under product code MRR (System, Test, Low Density, Lipoprotein), a Class I device regulated under 21 CFR 862.1475. Roche Diagnostic Systems, Inc. has at least 10 other 510(k) clearances on record.