Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K190412
Device Classification Name
Test, Opiates, Over The Counter
More FDA Info for this Device
510(K) Number
K190412
Device Name
Test, Opiates, Over The Counter
Applicant
Hangzhou Clongene Biotech Co.,Ltd.
Building 4, No.20 Longquan Road, Yuhang District
Hangzhou 311121 CN
Other 510(k) Applications for this Company
Contact
Zheng Shujian
Other 510(k) Applications for this Contact
Regulation Number
862.3650
More FDA Info for this Regulation Number
Classification Product Code
NGL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/21/2019
Decision Date
03/21/2019
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