510(k) K253188

CoaguChek XS Plus System by Roche Diagnostics — Product Code GJS

K253188 is an FDA 510(k) premarket notification submitted by Roche Diagnostics for the device "CoaguChek XS Plus System". The FDA issued a decision of Substantially Equivalent on October 24, 2025. The device falls under product code GJS (Test, Time, Prothrombin), a Class II device regulated under 21 CFR 864.7750. Roche Diagnostics has at least 10 other 510(k) clearances on record.