510(k) K012287

MODIFICATION TO: COBAS INTEGRA LDL-CHOLESTEROL PLUS 2ND GENERATION by Roche Diagnostics Corp. — Product Code MRR

K012287 is an FDA 510(k) premarket notification submitted by Roche Diagnostics Corp. for the device "MODIFICATION TO: COBAS INTEGRA LDL-CHOLESTEROL PLUS 2ND GENERATION". The FDA issued a decision of Substantially Equivalent on August 7, 2001. The device falls under product code MRR (System, Test, Low Density, Lipoprotein), a Class I device regulated under 21 CFR 862.1475. Roche Diagnostics Corp. has at least 10 other 510(k) clearances on record.