Name: Predicase
Price: 199 USD

K-number	K041174
Device name	CELIKEY TTG (HUMAN, RECOMBINANT) IGA ANTIBODIES MODEL #18148/18196
Applicant	Sweden Diagnostics (Germany) GmbH
Product code	MVM
Device class	Class II
Decision date	Jul 19, 2004
Decision	Substantially Equivalent
Regulation	866.5660

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 →

CELIKEY TTG (HUMAN, RECOMBINANT) IGA ANTIBODIES MODEL #18148/18196

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