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FDA 510(k)

WONDOFO MULTI-DRUG URINE TEST CUP / PANEL

K-Number: K130665 · 2013-04-09

ApplicantGuangzhou Wondfo Biotech Co., Ltd.
Decision Date2013-04-09
Product CodeDJG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

WONDOFO MULTI-DRUG URINE TEST CUP / PANEL is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Wondfo Biotech Co., Ltd.. It received FDA 510(k) clearance on 2013-04-09 under 510(k) number K130665. The device is classified under product code DJG. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WONDOFO MULTI-DRUG URINE TEST CUP / PANEL?

WONDOFO MULTI-DRUG URINE TEST CUP / PANEL is a medical device that received FDA 510(k) clearance on 2013-04-09. The listed applicant is Guangzhou Wondfo Biotech Co., Ltd.. The 510(k) number is K130665.

When did WONDOFO MULTI-DRUG URINE TEST CUP / PANEL receive FDA 510(k) clearance?

WONDOFO MULTI-DRUG URINE TEST CUP / PANEL received FDA 510(k) clearance on 2013-04-09, under 510(k) number K130665.

Who is the listed applicant for WONDOFO MULTI-DRUG URINE TEST CUP / PANEL?

The FDA 510(k) record lists Guangzhou Wondfo Biotech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WONDOFO MULTI-DRUG URINE TEST CUP / PANEL?

The FDA product code for WONDOFO MULTI-DRUG URINE TEST CUP / PANEL is DJG.

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Other records listing Guangzhou Wondfo Biotech Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260065SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel DxK252550SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup DxK251289WELLlife COVID-19 Antigen Test RxK241317Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)K241741SAFElife™ Fentanyl Urine Home Test (Cassette); SAFElife™ Fentanyl (FTY) Urine Test Cassette; SAFElife™ T-Dip Fentanyl Urine Home Test (Dip Card); SAFElife™ T-Dip Fentanyl (FTY) Urine Test PanelK202567Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel Rx

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Related Devices (Code: DJG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252684Labcorp Fentanyl Urine Visual TestMedtox Diagnostics, Inc.K250741Evidence MultiSTAT DOA Urine MultiPlexRandox Laboratories LimitedK253082LZI Buprenorphine II Enzyme ImmunoassayLin-Zhi International, Inc.K252520SEFRIA™ Hydrocodone Oral FluidImmunalysis CorporationK251972Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180)Healgen Scientific,, LLCK251634LZI Fentanyl III Enzyme ImmunoassayLin-Zhi International, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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