510(k) K033306

PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS CALIBRATORS by Roche Diagnostics Corp. — Product Code DKB

K033306 is an FDA 510(k) premarket notification submitted by Roche Diagnostics Corp. for the device "PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS CALIBRATORS". The FDA issued a decision of Substantially Equivalent on December 15, 2003. The device falls under product code DKB (Calibrators, Drug Mixture), a Class II device regulated under 21 CFR 862.3200. Roche Diagnostics Corp. has at least 10 other 510(k) clearances on record.