Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test Dipcard— 510(k) K241100

Name: FDA 510(k) clearance K241100
Creator: U.S. Food and Drug Administration
Published: 2024-05-22

Substantially Equivalent

Co-Innovation Biotech Co., Ltd.

FDA 510(k) clearance K241100 for Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test Dipcard, Substantially Equivalent on 2024-05-22. Applicant: Co-Innovation Biotech Co., Ltd.. Device class: 2.

Clearance details

Applicant: Co-Innovation Biotech Co., Ltd.
Product code: Code NGL
Device class: Class 2
Regulation: 21 CFR 862.3650
Advisory panel: Clinical Toxicology
Date received: 2024-04-22
Decision date: 2024-05-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guangzhou, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code NGL

view all

K253567 — Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card2025-12-23
K250803 — Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup2025-04-15
K250067 — Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup Pro2025-02-20
K242428 — Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Dochek® Fentanyl Urine Test Card, Dochek® Fentanyl Urine Test Card Plus, Dochek® Fentanyl Urine Test Cup and Dochek® Fentanyl Urine Test Cup Plus2025-02-06
K243365 — Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup2024-12-17

More clearances from Co-Innovation Biotech Co., Ltd.

view all

K231904 — Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard2024-03-08
K232732 — Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, Rapid Marijuana (THC) Test Strip 50, Rapid Marijuana (THC) Test Dipcard 502024-01-17
K213808 — Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Strip, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Cassette, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Midstream2022-04-05
K153050 — Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard2016-04-26
K142800 — Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard2014-12-11

Data sourced from openFDA. This site is unofficial and independent of the FDA.