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FDA 510(k)

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

K-Number: K241100 · 2024-05-22

ApplicantCo-Innovation Biotech Co., Ltd.
Decision Date2024-05-22
Product CodeNGL
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test Dipcard is a medical device manufactured by Co-Innovation Biotech Co., Ltd.. It received FDA 510(k) clearance on 2024-05-22 under approval number K241100. The device is classified under product code NGL. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test Dipcard?

Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test Dipcard is a medical device that received FDA 510(k) clearance on 2024-05-22. It is manufactured by Co-Innovation Biotech Co., Ltd.. The 510(k) number is K241100.

When was Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test Dipcard approved by the FDA?

Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test Dipcard received FDA 510(k) clearance on 2024-05-22, under approval number K241100.

What company makes Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test Dipcard?

Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test Dipcard is manufactured by Co-Innovation Biotech Co., Ltd..

What is the FDA product code for Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test Dipcard?

The FDA product code for Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test Dipcard is NGL.

Related Clinical Trials

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Other Devices by Co-Innovation Biotech Co., Ltd.

K153050Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard K213808Co-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 Midstream K231904Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard K232732Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, Rapid Marijuana (THC) Test Strip 50, Rapid Marijuana (THC) Test Dipcard 50

Related Devices (Code: NGL)

K181790CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy CupHangzhou Clongene Biotech Co., Ltd. K190412CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy CupHangzhou Clongene Biotech Co., Ltd. K193480BIOEASY Multi-Drug Test CupShenzhen Bioeasy Biotechnology Co., Ltd. K233417AllTest Fentanyl Urine Test CassetteHangzhou AllTest Biotech Co., Ltd. K243365Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test CupHealgen Scientific,, LLC K243064ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home TestEterbio, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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