Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel Rx

Test, Amphetamine, Over The Counter

Guangzhou Wondfo Biotech Co., Ltd.

The following data is part of a premarket notification filed by Guangzhou Wondfo Biotech Co., Ltd. with the FDA for Wondfo T-dip Multi-drug Urine Test Panel, Wondfo T-dip Multi-drug Urine Test Panel Rx.

Pre-market Notification Details

Device IDK202567
510k NumberK202567
Device Name:Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel Rx
ClassificationTest, Amphetamine, Over The Counter
Applicant Guangzhou Wondfo Biotech Co., Ltd. No. 8 Lizhishan Road, Science City Guangzhou,  CN 510641
ContactYi Mei
CorrespondentJoe Shia
LSI International 504 E Diamond Ave., Suite I Gaithersburg,  MD  20877
Product CodeNFT  
Subsequent Product CodeLCM
Subsequent Product CodeNFV
Subsequent Product CodeNFW
Subsequent Product CodeNFY
Subsequent Product CodeNGG
Subsequent Product CodeNGL
Subsequent Product CodePTG
Subsequent Product CodePTH
Subsequent Product CodeQAW
Subsequent Product CodeQBF
CFR Regulation Number862.3100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-04
Decision Date2020-09-25

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