Cleared Traditional

Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test Dipcard

K241100 · Co-Innovation Biotech Co., Ltd. · Toxicology
May 2024
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K241100 is an FDA 510(k) clearance for the Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test Dipcard, a Test, Opiates, Over The Counter (Class II — Special Controls, product code NGL), submitted by Co-Innovation Biotech Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on May 22, 2024, 30 days after receiving the submission on April 22, 2024. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3650.

Submission Details

510(k) Number K241100 FDA.gov
FDA Decision Cleared SESE
Date Received April 22, 2024
Decision Date May 22, 2024
Days to Decision 30 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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