510(k) K080183

CONTROL SET DAT I, CONTRL SET DAT II, CONTROL SET DAT III, CONTROL SET AMPHETAMINE 1000 AND CONTROL SET AMPHETAMINE 500 by Roche Diagnostics Corp. — Product Code DIF

K080183 is an FDA 510(k) premarket notification submitted by Roche Diagnostics Corp. for the device "CONTROL SET DAT I, CONTRL SET DAT II, CONTROL SET DAT III, CONTROL SET AMPHETAMINE 1000 AND CONTROL SET AMPHETAMINE 500". The FDA issued a decision of Substantially Equivalent on March 25, 2008. The device falls under product code DIF (Drug Mixture Control Materials), a Class I device regulated under 21 CFR 862.3280. Roche Diagnostics Corp. has at least 10 other 510(k) clearances on record.