Name: Predicase
Price: 199 USD

K-number	K080159
Device name	KRONUS TSH RECEPTOR AUTOANTIBODY (TRAB) ELISA ASSAY KIT
Applicant	Kronus Market Development Associates, Inc.
Product code	JZO
Device class	Class II
Decision date	May 22, 2008
Decision	Substantially Equivalent
Regulation	866.5870

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 →

KRONUS TSH RECEPTOR AUTOANTIBODY (TRAB) ELISA ASSAY KIT

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