K-number	K161951
Device name	KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay
Applicant	Kronus, Inc.
Product code	PNI
Device class	Class II
Decision date	Jul 22, 2016
Decision	Substantially Equivalent
Regulation	866.5665

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 →

KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay

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