K-number	K253188
Device name	CoaguChek XS Plus System
Applicant	Roche Diagnostics
Product code	GJS
Device class	Class II
Decision date	Oct 24, 2025
Decision	Substantially Equivalent
Regulation	864.7750

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

Researching this as a predicate?

Want a transparent AI-ranking score, AI-discovered related predicates, ongoing safety and warning-letter monitoring, full predicate chain lineage, and a drafted SE rationale — all saved to your own project? That's what an account adds.

Start free trial →

Building an AI or ML-enabled device? Predicate search, PCCP tracking, and AI-specific FDA intelligence — built exclusively for AI/ML devices. Try AIFDA Intel →

CoaguChek XS Plus System

Everything you need for a 510(k) submission. Nothing you don't.