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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Microbial Nucleic Acid Storage And Stabilization Device
510(k) Number K212878
Device Name Sample preservation solution
Applicant
Zhejiang Gene Science Co., Ltd.
#2 Workshop,Pharmaceutical Industrial Park,#11 Shengxing
Rd.,Shangyu Economic Tech
Shaoxing,  CN 312300
Applicant Contact Zhang Feng
Correspondent
Guangzhou Osmunda Medical Device Technical Services Co., Ltd.
8-9th Floor, R&D Bldg., #26 Qinglan St., Panyu
District
Guangzhou,  CN 510006
Correspondent Contact Olivia Meng
Classification Product Code
QBD  
Date Received09/09/2021
Decision Date 04/08/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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