Name: Predicase
Price: 199 USD

K-number	K191562
Device name	Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor
Applicant	HORIBA ABX SAS
Product code	DBF
Device class	Class II
Decision date	Mar 6, 2020
Decision	Substantially Equivalent
Regulation	866.5340

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 →

Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor

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