Cleared Special

CoaguChek XS Plus System

K253188 · Roche Diagnostics · Hematology
Oct 2025
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K253188 is an FDA 510(k) clearance for the CoaguChek XS Plus System, a Test, Time, Prothrombin (Class II — Special Controls, product code GJS), submitted by Roche Diagnostics (Indianapolos, US). The FDA issued a Cleared decision on October 24, 2025, 28 days after receiving the submission on September 26, 2025. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7750.

Submission Details

510(k) Number K253188 FDA.gov
FDA Decision Cleared SESE
Date Received September 26, 2025
Decision Date October 24, 2025
Days to Decision 28 days
Submission Type Special
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GJS — Test, Time, Prothrombin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7750