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FDA 510(k) Application Details - K231978
Device Classification Name
Test, Cannabinoid, Over The Counter
More FDA Info for this Device
510(K) Number
K231978
Device Name
Test, Cannabinoid, Over The Counter
Applicant
VivaChek Biotech (Hangzhou) Co., Ltd
Floor 2, Block 2, 146 East Chaofeng Road
Yuhang Economy Development Zone
Hangzhou 311100 CN
Other 510(k) Applications for this Company
Contact
Jessica Chen
Other 510(k) Applications for this Contact
Regulation Number
862.3870
More FDA Info for this Regulation Number
Classification Product Code
NFW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/03/2023
Decision Date
08/31/2023
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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