Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K181968
Device Classification Name
Test, Amphetamine, Over The Counter
More FDA Info for this Device
510(K) Number
K181968
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
07/24/2018
Decision Date
08/20/2018
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