Cleared Traditional

CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette

K242802 · Hangzhou Clongene Biotech Co., Ltd. · Toxicology
Nov 2024
Decision
52d
Days
Class 2
Risk

About This 510(k) Submission

K242802 is an FDA 510(k) clearance for the CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette, a Test, Opiates, Over The Counter (Class II — Special Controls, product code NGL), submitted by Hangzhou Clongene Biotech Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on November 8, 2024, 52 days after receiving the submission on September 17, 2024. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3650.

Submission Details

510(k) Number K242802 FDA.gov
FDA Decision Cleared SESE
Date Received September 17, 2024
Decision Date November 08, 2024
Days to Decision 52 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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