510(k) K053499

HEMOSIL PROS by Instrumentation Laboratory CO — Product Code GGP

K053499 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "HEMOSIL PROS". The FDA issued a decision of Substantially Equivalent on January 13, 2006. The device falls under product code GGP (Test, Qualitative And Quantitative Factor Deficiency), a Class II device regulated under 21 CFR 864.7290. Instrumentation Laboratory CO has at least 10 other 510(k) clearances on record.