510(k) K060788

TRIAGE TOX DRUG SCREEN CONTROL LEVEL 1 MODEL 94413 AND LEVEL 2 MODEL 94414 by Biosite Incorporated — Product Code DIF

K060788 is an FDA 510(k) premarket notification submitted by Biosite Incorporated for the device "TRIAGE TOX DRUG SCREEN CONTROL LEVEL 1 MODEL 94413 AND LEVEL 2 MODEL 94414". The FDA issued a decision of Substantially Equivalent on July 10, 2006. The device falls under product code DIF (Drug Mixture Control Materials), a Class I device regulated under 21 CFR 862.3280. Biosite Incorporated has at least 10 other 510(k) clearances on record.