ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home Test— 510(k) K243064

Substantially Equivalent

Eterbio, Inc.

FDA 510(k) clearance K243064 for ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home Test, Substantially Equivalent on 2024-11-20. Applicant: Eterbio, Inc..

Clearance details

Applicant: Eterbio, Inc.
Product code: Code NGL
Advisory panel: Clinical Toxicology
Date received: 2024-09-27
Decision date: 2024-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Zhuhai, CN

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.