Class Class II

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 Plus (K242428)

K242428 2025-02-06 Traditional
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Description

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 Plus by Guangzhou Decheng Biotechnology Co., Ltd. — FDA 510(k) cleared clinical toxicology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK242428
Clearance Date2025-02-06
Clearance TypeTraditional
Product CodeNGL
Regulation Number862.3650

Categories

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