K-number	K041817
Device name	WEST NILE DETECT IGM ELISA
Applicant	Inbios Intl., Inc.
Product code	NOP
Device class	Class II
Decision date	Nov 19, 2004
Decision	Substantially Equivalent
Regulation	866.3940

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 →

WEST NILE DETECT IGM ELISA

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