510(k) K212183

STA R Max 3, STA Compact Max 3 by Diagnostica Stago S.A.S — Product Code JPA

K212183 is an FDA 510(k) premarket notification submitted by Diagnostica Stago S.A.S for the device "STA R Max 3, STA Compact Max 3". The FDA issued a decision of Substantially Equivalent on June 7, 2023. The device falls under product code JPA (System, Multipurpose For In Vitro Coagulation Studies), a Class II device regulated under 21 CFR 864.5425. Diagnostica Stago S.A.S has at least 10 other 510(k) clearances on record.