Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K180879
Device Classification Name
Enzyme Immunoassay, Amphetamine
More FDA Info for this Device
510(K) Number
K180879
Device Name
Enzyme Immunoassay, Amphetamine
Applicant
SHANGHAI VENTURE BIO-TECH CO., LTD.
Room 313, Building 2, No. 2715 Longwu Road, Xuhui District
Shanghai 200231 CN
Other 510(k) Applications for this Company
Contact
Longli Long
Other 510(k) Applications for this Contact
Regulation Number
862.3100
More FDA Info for this Regulation Number
Classification Product Code
DKZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/03/2018
Decision Date
12/14/2018
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