K-number	K031953
Device name	WEST NILE VIRUS ELISA IGG, MODEL EL0300G
Applicant	Focus Technologies, Inc.
Product code	NOP
Device class	Class II
Decision date	Oct 22, 2003
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 VIRUS ELISA IGG, MODEL EL0300G

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