K-number	DEN140010
Device name	PERKINELMER ENLITE NEONATAL TREC TEST SYSTEM
Applicant	Wallac OY
Product code	PJI
Device class	Class II
Decision date	Dec 15, 2014
Decision	Not Substantially Equivalent
Regulation	866.5930

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 →

PERKINELMER ENLITE NEONATAL TREC TEST SYSTEM

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