Cleared Traditional

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

K243064 · Eterbio, Inc. · Toxicology
Nov 2024
Decision
54d
Days
Class 2
Risk

About This 510(k) Submission

K243064 is an FDA 510(k) clearance for the ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home Test, a Test, Opiates, Over The Counter (Class II — Special Controls, product code NGL), submitted by Eterbio, Inc. (Zhuhai, CN). The FDA issued a Cleared decision on November 20, 2024, 54 days after receiving the submission on September 27, 2024. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3650.

Submission Details

510(k) Number K243064 FDA.gov
FDA Decision Cleared SESE
Date Received September 27, 2024
Decision Date November 20, 2024
Days to Decision 54 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code NGL — Test, Opiates, Over The Counter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3650

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