Name: Predicase
Price: 199 USD

K-number	K242802
Device name	CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette
Applicant	Hangzhou Clongene Biotech Co., Ltd.
Product code	NGL
Device class	Class II
Decision date	Nov 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 →

CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette

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