510(k) K211485

STA- NeoPTimal by Diagnostica Stago S.A.S — Product Code GJS

K211485 is an FDA 510(k) premarket notification submitted by Diagnostica Stago S.A.S for the device "STA- NeoPTimal". The FDA issued a decision of Substantially Equivalent on December 23, 2022. The device falls under product code GJS (Test, Time, Prothrombin), a Class II device regulated under 21 CFR 864.7750. Diagnostica Stago S.A.S has at least 10 other 510(k) clearances on record.