FDA 510(k)

WONDFO CANNABINOIDS URINE TEST WONDFO PROPOXYPHENE URINE TEST

K-Number: K121557 · 2012-07-25

ApplicantGuangzhou Wondfo Biotech Co., Ltd.

Decision Date2012-07-25

Product CodeLDJ

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

WONDFO CANNABINOIDS URINE TEST WONDFO PROPOXYPHENE URINE TEST 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 2012-07-25 under 510(k) number K121557. The device is classified under product code LDJ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WONDFO CANNABINOIDS URINE TEST WONDFO PROPOXYPHENE URINE TEST?

WONDFO CANNABINOIDS URINE TEST WONDFO PROPOXYPHENE URINE TEST is a medical device that received FDA 510(k) clearance on 2012-07-25. The listed applicant is Guangzhou Wondfo Biotech Co., Ltd.. The 510(k) number is K121557.

When did WONDFO CANNABINOIDS URINE TEST WONDFO PROPOXYPHENE URINE TEST receive FDA 510(k) clearance?

WONDFO CANNABINOIDS URINE TEST WONDFO PROPOXYPHENE URINE TEST received FDA 510(k) clearance on 2012-07-25, under 510(k) number K121557.

Who is the listed applicant for WONDFO CANNABINOIDS URINE TEST WONDFO PROPOXYPHENE URINE TEST?

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 WONDFO CANNABINOIDS URINE TEST WONDFO PROPOXYPHENE URINE TEST?

The FDA product code for WONDFO CANNABINOIDS URINE TEST WONDFO PROPOXYPHENE URINE TEST is LDJ.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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

K260065SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel Dx K252550SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx K251289WELLlife COVID-19 Antigen Test Rx K241317Wondfo 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 Panel K202567Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel Rx

View all 31 devices →

Related Devices (Code: LDJ)

K232732Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, Rapid Marijuana (THC) Test Strip 50, Rapid Marijuana (THC) Test Dipcard 50Co-Innovation Biotech Co., Ltd.K232604LYHER® Urine Marijuana (THC) Test Kit (Strip), LYHER® Urine Marijuana (THC) Test Kit (Cassette)Hangzhou Laihe Biotech Co., Ltd.K223162Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COTHealgen Scientific,, LLC K192515BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY Marijuana Test Strip 40, BIOEASY Marijuana Test Strip 20Shenzhen Bioeasy Biotechnology Co., Ltd.K153741CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana TestHangzhou Clongene Biotech Co., Ltd.K130213QUICKPROFILE SINGLE DRUG OF ABUSE DEVICE AND QUICK PROFILE MULTI-DRUGS OF ABUSE SCREEN DEVICELumiquick Diagnostics, 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.