K-number	K994112
Device name	MANUAL HER-2/NEU MICROTITER ELISA (OSDI HER-2/NEU ELISA)
Applicant	Oncogene Science, Inc.
Product code	NCW
Device class	Class II
Decision date	Sep 29, 2000
Decision	Substantially Equivalent
Regulation	866.6010

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 →

MANUAL HER-2/NEU MICROTITER ELISA (OSDI HER-2/NEU ELISA)

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