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510(k) K240698

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 10, 2024
Date Received
March 14, 2024
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.

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  • 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)
  • K232659 — Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test Cup (December 13, 2023)
  • 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

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  • 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)
  • 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)
  • K232597 — LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette (January 9, 2024)