510(k) K230852

HemosIL Chromogenic Factor IX by Instrumentation Laboratory Company — Product Code GGP

K230852 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory Company for the device "HemosIL Chromogenic Factor IX". The FDA issued a decision of Substantially Equivalent on December 13, 2023. 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 Company has at least 10 other 510(k) clearances on record.