510(k) K033165

PRECISET DAT AMPHETAMINE CALIBRATORS; CFAS DAT QUALITATIVE AMPHETAMINE CALIBRATORS by Roche Diagnostics Corp. — Product Code DLJ

K033165 is an FDA 510(k) premarket notification submitted by Roche Diagnostics Corp. for the device "PRECISET DAT AMPHETAMINE CALIBRATORS; CFAS DAT QUALITATIVE AMPHETAMINE CALIBRATORS". The FDA issued a decision of Substantially Equivalent on October 14, 2003. The device falls under product code DLJ (Calibrators, Drug Specific), a Class II device regulated under 21 CFR 862.3200. Roche Diagnostics Corp. has at least 10 other 510(k) clearances on record.