Name: Predicase
Price: 199 USD

K-number	K240295
Device name	InstaStrip Fentanyl Rapid Test (Urine); InstaStrip Fentanyl Dipstick Test (Urine)
Applicant	Instanosis, Inc.
Product code	NGL
Device class	Class II
Decision date	Mar 28, 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 →

InstaStrip Fentanyl Rapid Test (Urine); InstaStrip Fentanyl Dipstick Test (Urine)

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