Wisdiag Multi-Drug Urine Test Cup, Wisdiag Multi-Drug Urine Test Cup Rx

Test, Amphetamine, Over The Counter

Vivachek Biotech (Hangzhou) Co., Ltd

The following data is part of a premarket notification filed by Vivachek Biotech (hangzhou) Co., Ltd with the FDA for Wisdiag Multi-drug Urine Test Cup, Wisdiag Multi-drug Urine Test Cup Rx.

Pre-market Notification Details

Device IDK222667
510k NumberK222667
Device Name:Wisdiag Multi-Drug Urine Test Cup, Wisdiag Multi-Drug Urine Test Cup Rx
ClassificationTest, Amphetamine, Over The Counter
Applicant Vivachek Biotech (Hangzhou) Co., Ltd Level 2, Block 2, 146 East Chaofeng Road Yuhang Economy Development Zone Hangzhou,  CN 311100
ContactJessica Chen
CorrespondentJoe Shia
LSI International 540 E Diamond Avenue, 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)
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-09-06
Decision Date2022-11-10

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