K-number	DEN230036
Device name	Sepsis ImmunoScore
Applicant	Prenosis, Inc.
Product code	SAK
Device class	Class II
Decision date	Apr 2, 2024
Decision	Not Substantially Equivalent
Regulation	880.6316

AI Summary

AI extraction for this record is queued and will appear within 24 hours. View full FDA record →

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 →

Sepsis ImmunoScore

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