Name: Predicase
Price: 199 USD

K-number	K081286
Device name	MONOCLONAL RABBIT ANTI HUMAN ESTROGEN RECEPTOR ALPHA ANTIBODY CLONE SP1, MODEL M3634
Applicant	Dako North America, Inc.
Product code	MYA
Device class	Class II
Decision date	May 8, 2009
Decision	Substantially Equivalent
Regulation	864.1860

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 →

MONOCLONAL RABBIT ANTI HUMAN ESTROGEN RECEPTOR ALPHA ANTIBODY CLONE SP1, MODEL M3634

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