Name: Predicase
Price: 199 USD

K-number	K234006
Device name	AllSource Drug Detector FenTest; AllSource Drug Detector Fentanyl Test
Applicant	Allsource Screening Solutions
Product code	NGL
Device class	Class II
Decision date	Mar 21, 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 →

AllSource Drug Detector FenTest; AllSource Drug Detector Fentanyl Test

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