Name: Predicase
Price: 199 USD

K-number	K243064
Device name	ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home Test
Applicant	Eterbio, Inc.
Product code	NGL
Device class	Class II
Decision date	Nov 20, 2024
Decision	Substantially Equivalent
Regulation	862.3650

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home Test

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