K-number	K103358
Device name	ROMA (HE4 EIA + ARCHITECT CA 125 II)
Applicant	Fujirebio Diagnostics,Inc.
Product code	ONX
Device class	Class II
Decision date	Sep 1, 2011
Decision	Unknown
Regulation	866.6050

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 →

ROMA (HE4 EIA + ARCHITECT CA 125 II)

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