Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K192301
Device Classification Name
Test, Cannabinoid, Over The Counter
More FDA Info for this Device
510(K) Number
K192301
Device Name
Test, Cannabinoid, Over The Counter
Applicant
Shenzhen Bioeasy Biotechnology Co.,Ltd.
No.2-1,Liuxian 1st Road,Xin'an Sub-District
Shenzhen 518101 CN
Other 510(k) Applications for this Company
Contact
Wenhau Yan
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
08/23/2019
Decision Date
09/20/2019
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
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact