510(k) K102164

HEMOSIL PROTEIN S ACTIVITY ASSAY by Instrumentation Laboratory CO — Product Code GGP

K102164 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "HEMOSIL PROTEIN S ACTIVITY ASSAY". The FDA issued a decision of Substantially Equivalent on March 17, 2011. 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.