Cleared Traditional

SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette

K240654 · Safecare Biotech (Hangzhou) Co., Ltd. · Toxicology
Apr 2024
Decision
34d
Days
Class 2
Risk

About This 510(k) Submission

K240654 is an FDA 510(k) clearance for the SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette, a Test, Opiates, Over The Counter (Class II — Special Controls, product code NGL), submitted by Safecare Biotech (Hangzhou) Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on April 10, 2024, 34 days after receiving the submission on March 7, 2024. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3650.

Submission Details

510(k) Number K240654 FDA.gov
FDA Decision Cleared SESE
Date Received March 07, 2024
Decision Date April 10, 2024
Days to Decision 34 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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