SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card

Test, Amphetamine, Over The Counter

Safecare Biotech(Hangzhou)Co.,Ltd.

The following data is part of a premarket notification filed by Safecare Biotech(hangzhou)co.,ltd. with the FDA for Safecare Multi-drug Urine Test Cup, Safecare Multi-drug Urine Test Dip-card.

Pre-market Notification Details

Device IDK202453
510k NumberK202453
Device Name:SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card
ClassificationTest, Amphetamine, Over The Counter
Applicant Safecare Biotech(Hangzhou)Co.,Ltd. Building 2/203 No.18 Haishu Rd., Cangqian Sub-district Yuhang District Hangzhou,  CN 311121
ContactAlex Qiu
CorrespondentJoe Shia
LSI International 504 E Diamond Ave., Suite I Gaithersburg,  MD  20877
Product CodeNFT  
Subsequent Product CodeNFV
Subsequent Product CodeNFW
Subsequent Product CodeNFY
Subsequent Product CodeNGG
Subsequent Product CodeNGI
Subsequent Product CodeNGL
Subsequent Product CodeNGM
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 Received2020-08-27
Decision Date2021-03-24

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