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

Test, Amphetamine, Over The Counter

Qingdao HIGHTOP Biotech Co., Ltd.

The following data is part of a premarket notification filed by Qingdao Hightop Biotech Co., Ltd. with the FDA for Hightop Multi-drug Urine Test Cup, Hightop Multi-drug Urine Test Cup Rx.

Pre-market Notification Details

Device IDK220685
510k NumberK220685
Device Name:HIGHTOP Multi-Drug Urine Test Cup, HIGHTOP Multi-Drug Urine Test Cup Rx
ClassificationTest, Amphetamine, Over The Counter
Applicant Qingdao HIGHTOP Biotech Co., Ltd. No.369 Hedong Road, Hi-tech Industrial Development Zone Qingdao,  CN 266112
ContactRay Li
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)
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-08
Decision Date2022-05-05

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