510(k) K172197

SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS by Origio A/S — Product Code MQL

K172197 is an FDA 510(k) premarket notification submitted by Origio A/S for the device "SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS". The FDA issued a decision of Substantially Equivalent on October 13, 2017. The device falls under product code MQL (Media, Reproductive), a Class II device regulated under 21 CFR 884.6180. Origio A/S has at least 10 other 510(k) clearances on record.