510(k) K070635

HEMOSIL PROCLOT by Instrumentation Laboratory CO — Product Code GGP

K070635 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "HEMOSIL PROCLOT". The FDA issued a decision of Substantially Equivalent on March 29, 2007. 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.