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510(k) K131232

WONDFO METHADONE URINE TEST (MTD 200), WONDOFO MORPHINE URINE TEST (MOP 100) by Guangzhou Wondfo Biotech Co., Ltd. — Product Code DJR

K131232 is an FDA 510(k) premarket notification submitted by Guangzhou Wondfo Biotech Co., Ltd. for the device "WONDFO METHADONE URINE TEST (MTD 200), WONDOFO MORPHINE URINE TEST (MOP 100)". The FDA issued a decision of Substantially Equivalent on May 31, 2013. The device falls under product code DJR (Enzyme Immunoassay, Methadone), a Class II device regulated under 21 CFR 862.3620. Guangzhou Wondfo Biotech Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 31, 2013
Date Received
May 1, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Methadone
Device Class
Class II
Regulation Number
862.3620
Review Panel
TX
Submission Type

Other clearances by Guangzhou Wondfo Biotech Co., Ltd.

  • K260065 — SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test (April 28, 2026)
  • K252550 — SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test C (November 18, 2025)
  • K251289 — WELLlife COVID-19 Antigen Test Rx (October 22, 2025)
  • K241317 — Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) (September 30, 2024)
  • K241741 — SAFElife™ Fentanyl Urine Home Test (Cassette); SAFElife™ Fentanyl (FTY) Urine Te (July 16, 2024)
  • K202567 — Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Pan (September 25, 2020)
  • K182701 — Wondfo T-Cup Multi-Drug Urine Test Cup (December 3, 2018)
  • K173229 — Preview Digital Pregnancy Test (March 12, 2018)
  • K162333 — Wondfo One Step Fecal Occult Blood (FOB) Test (May 14, 2017)
  • K161214 — Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine Test (June 27, 2016)

Other clearances for product code DJR

  • K192433 — LZI Methadone II Enzyme Immunoassay (October 4, 2019)
  • K182779 — ARK EDDP Assay (November 21, 2018)
  • K170416 — LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 3 (June 26, 2017)
  • K160793 — First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign D (August 17, 2016)
  • K152025 — AssureTech Buprenorphine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup) (October 5, 2015)
  • K151395 — Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calib (July 24, 2015)
  • K151441 — First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test (June 29, 2015)
  • K092272 — RANDOX METHADONE ASSAY (November 18, 2010)
  • K092258 — RANDOX METABOLITE (EDDP) ASSAY (November 9, 2010)
  • K092048 — ONE STEP EDDP (METHADONE METABOLITE) TEST STRIP (April 19, 2010)

FDA data resources