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510(k) K250067

Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup Pro by Guangzhou Decheng Biotechnology Co., Ltd. — Product Code NGL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 20, 2025
Date Received
January 10, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Opiates, Over The Counter
Device Class
Class II
Regulation Number
862.3650
Review Panel
TX
Submission Type

Other clearances by Guangzhou Decheng Biotechnology Co., Ltd.

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  • K240698 — Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug Urine Test Dipcard (May 10, 2024)
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  • K230038 — MissLan® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream) (February 28, 2023)
  • K222305 — MissLan™ Digital Pregnancy Rapid Test (November 30, 2022)

Other clearances for product code NGL

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  • K242428 — Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Doche (February 6, 2025)
  • K243365 — Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Dru (December 17, 2024)
  • K243064 — ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfe (November 20, 2024)
  • K242802 — CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette (November 8, 2024)
  • K241869 — BioSieve™ Fentanyl FIA Home Test Kit; BioSieve™ Fentanyl FIA Pro Test Kit; BioSi (October 4, 2024)
  • K241969 — Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop® Fentanyl (August 14, 2024)
  • K241741 — SAFElife™ Fentanyl Urine Home Test (Cassette); SAFElife™ Fentanyl (FTY) Urine Te (July 16, 2024)
  • K241100 — Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test Dipcard (May 22, 2024)