510(k) K031856

PRECISET TDM I AND PRECISET TDM II CALIBRATORS by Roche Diagnostics Corp. — Product Code DKB

K031856 is an FDA 510(k) premarket notification submitted by Roche Diagnostics Corp. for the device "PRECISET TDM I AND PRECISET TDM II CALIBRATORS". The FDA issued a decision of Substantially Equivalent on August 6, 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.