510(k) K092987

INRATIO/INRATIO2 TEST STRIPS by Biosite Incorporated — Product Code GJS

K092987 is an FDA 510(k) premarket notification submitted by Biosite Incorporated for the device "INRATIO/INRATIO2 TEST STRIPS". The FDA issued a decision of Substantially Equivalent on June 11, 2010. The device falls under product code GJS (Test, Time, Prothrombin), a Class II device regulated under 21 CFR 864.7750. Biosite Incorporated has at least 10 other 510(k) clearances on record.