510(k) K040459

TRIAGE PROFILER S.O.B. CONTROLS AND S.O.B. CALIBRATION VERIFICATION CONTROLS by Biosite Incorporated — Product Code JJY

K040459 is an FDA 510(k) premarket notification submitted by Biosite Incorporated for the device "TRIAGE PROFILER S.O.B. CONTROLS AND S.O.B. CALIBRATION VERIFICATION CONTROLS". The FDA issued a decision of Substantially Equivalent on July 6, 2004. The device falls under product code JJY (Multi-Analyte Controls, All Kinds (Assayed)), a Class I device regulated under 21 CFR 862.1660. Biosite Incorporated has at least 10 other 510(k) clearances on record.