Home / 510(k) Clearances / K232659

510(k) K232659

Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test Cup by Guangzhou Decheng Biotechnology Co., Ltd. — Product Code DJG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 2023
Date Received
August 31, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Opiates
Device Class
Class II
Regulation Number
862.3650
Review Panel
TX
Submission Type

Other clearances by Guangzhou Decheng Biotechnology Co., Ltd.

  • K251040 — MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital P (September 9, 2025)
  • K250067 — Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup Pro (February 20, 2025)
  • K242428 — Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Doche (February 6, 2025)
  • K240643 — MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnanc (June 21, 2024)
  • K240698 — Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug Urine Test Dipcard (May 10, 2024)
  • 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 DJG

  • K252684 — Labcorp Fentanyl Urine Visual Test (January 29, 2026)
  • K250741 — Evidence MultiSTAT DOA Urine MultiPlex (January 23, 2026)
  • K253082 — LZI Buprenorphine II Enzyme Immunoassay (January 16, 2026)
  • K252520 — SEFRIA™ Hydrocodone Oral Fluid (September 11, 2025)
  • K251972 — Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative (August 15, 2025)
  • K251634 — LZI Fentanyl III Enzyme Immunoassay (June 18, 2025)
  • K240124 — BioSieve™ Fentanyl FIA Test Kit; BioSieve™ ToxiSmart FIA Reader (June 14, 2024)
  • K240698 — Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug Urine Test Dipcard (May 10, 2024)
  • K231904 — Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard (March 8, 2024)
  • K232228 — Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug (February 23, 2024)