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FDA 510(k) Applications Submitted by Hangzhou Clongene Biotech Co.,Ltd.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K180255
01/30/2018
CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup
Hangzhou Clongene Biotech Co.,Ltd.
K190412
02/21/2019
CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup
Hangzhou Clongene Biotech Co.,Ltd.
K181790
07/05/2018
CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup
Hangzhou Clongene Biotech Co.,Ltd.
K193132
11/12/2019
CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test Strip, CLUNGENE HCG Pregnancy Rapid Test Midstream
Hangzhou Clongene Biotech Co.,Ltd.
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