510(k) K062840

TRIAGE PROTEIN C CONTROLS AND CALIBRATION VERIFICATION CONTROLS by Biosite Incorporated — Product Code GGN

K062840 is an FDA 510(k) premarket notification submitted by Biosite Incorporated for the device "TRIAGE PROTEIN C CONTROLS AND CALIBRATION VERIFICATION CONTROLS". The FDA issued a decision of Substantially Equivalent on March 1, 2007. The device falls under product code GGN (Plasma, Coagulation Control), a Class II device regulated under 21 CFR 864.5425. Biosite Incorporated has at least 10 other 510(k) clearances on record.