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FDA 510(k) Application Details - K180255
Device Classification Name
More FDA Info for this Device
510(K) Number
K180255
Device Name
CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup
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
More FDA Info for this Regulation Number
Classification Product Code
PTH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/30/2018
Decision Date
02/28/2018
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
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