FDA.report

510(k) K211675

Device
Dasky Disposable Sampling Tube (Model name: VSM02)
Applicant
Ningbo Dasky Life Science Co., Ltd.
510(k) number
K211675
Product code
QBD
Decision
Substantially Equivalent (SESE)
Decision date
2022-08-08
Date received
2021-06-01
Regulation
866.2950
Classification name
Microbial Nucleic Acid Storage And Stabilization Device
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Wilson Wong
Address
# 6, Donggong 1st Rd., Yinzhou District Ningbo CN 315000 315000

FDA Registration Numbers

Source Documents

510(k) summary PDF

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