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FDA 510(k) Application Details - K202453
Device Classification Name
Test, Amphetamine, Over The Counter
More FDA Info for this Device
510(K) Number
K202453
Device Name
Test, Amphetamine, Over The Counter
Applicant
Safecare Biotech(Hangzhou)Co.,Ltd.
Building 2/203 No.18 Haishu Rd., Cangqian Sub-district
Yuhang District
Hangzhou 311121 CN
Other 510(k) Applications for this Company
Contact
Alex Qiu
Other 510(k) Applications for this Contact
Regulation Number
862.3100
More FDA Info for this Regulation Number
Classification Product Code
NFT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/27/2020
Decision Date
03/24/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
TX - Clinical Toxicology
Review Advisory Committee
TX - Clinical Toxicology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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