510(k) K990594

INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN A-1 by Roche Diagnostics Corp. — Product Code DER

K990594 is an FDA 510(k) premarket notification submitted by Roche Diagnostics Corp. for the device "INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN A-1". The FDA issued a decision of Substantially Equivalent on April 14, 1999. The device falls under product code DER (Alpha-1-Lipoprotein, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5580. Roche Diagnostics Corp. has at least 10 other 510(k) clearances on record.