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510(k) K132630

WONDFO OXAZEPAM URINE TEST (BZO 200) AND WONDFO METHAMPHETAMINE URINE TEST (MET 300) by Guangzhou Wondfo Biotech Co., Ltd. — Product Code DJC

K132630 is an FDA 510(k) premarket notification submitted by Guangzhou Wondfo Biotech Co., Ltd. for the device "WONDFO OXAZEPAM URINE TEST (BZO 200) AND WONDFO METHAMPHETAMINE URINE TEST (MET 300)". The FDA issued a decision of Substantially Equivalent on September 27, 2013. The device falls under product code DJC (Thin Layer Chromatography, Methamphetamine), a Class II device regulated under 21 CFR 862.3610. Guangzhou Wondfo Biotech Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 2013
Date Received
August 22, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Thin Layer Chromatography, Methamphetamine
Device Class
Class II
Regulation Number
862.3610
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 DJC

  • K253705 — Healgen® Accurate Oral Fluid Drug Test (March 16, 2026)
  • K240287 — LYHER® Oral fluid Multi-Drug Test Kit (Cube) (March 18, 2025)
  • K180878 — BIO-VENTURE Rapid Amphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Oxaze (December 17, 2018)
  • K181305 — OralTox Oral fluid Drug Test (September 20, 2018)
  • K171403 — OralTox Oral Fluid Drug Test (February 2, 2018)
  • K161044 — AssureTech Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split (July 6, 2016)
  • K080347 — UNISCAN -DOA SYSTEM (October 9, 2008)
  • K060355 — ACRO BIOTECH LLC RAPID MDMA URINE TEST, CATALOG MDMA0010000 (August 7, 2006)
  • K060896 — MODIFICATION TO ONTRAK TESTCUP II AND ONSITE CUPKIT (June 9, 2006)
  • K053033 — ACRO BIOTECH LLC RAPID METHAMPHETAMINE URINE TEST; CATALOG# MET001000 (June 6, 2006)

FDA data resources