FDA 510(k) Application Details - K191924

Device Classification Name	Test, Cannabinoid, Over The Counter   More FDA Info for this Device
510(K) Number	K191924
Device Name	Test, Cannabinoid, 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	862.3870   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	07/18/2019
Decision Date	08/16/2019
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