Cleared Traditional

Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard

K231904 · Co-Innovation Biotech Co., Ltd. · Toxicology
Mar 2024
Decision
254d
Days
Class 2
Risk

About This 510(k) Submission

K231904 is an FDA 510(k) clearance for the Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard, a Enzyme Immunoassay, Opiates (Class II — Special Controls, product code DJG), submitted by Co-Innovation Biotech Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on March 8, 2024, 254 days after receiving the submission on June 28, 2023. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3650.

Submission Details

510(k) Number K231904 FDA.gov
FDA Decision Cleared SESE
Date Received June 28, 2023
Decision Date March 08, 2024
Days to Decision 254 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DJG — Enzyme Immunoassay, Opiates
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3650

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