Name: Predicase
Price: 199 USD

K-number	K231904
Device name	Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard
Applicant	Co-Innovation Biotech Co., Ltd.
Product code	DJG
Device class	Class II
Decision date	Mar 8, 2024
Decision	Substantially Equivalent
Regulation	862.3650

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 →

Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard

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