FDA.report

510(k) K210440

Device
Disposable Sampler Inactivated Transport Media, Nest ITM
Applicant
Wuxi Nest Biotechnology Co., Ltd.
510(k) number
K210440
Product code
QBD
Decision
Substantially Equivalent (SESE)
Decision date
2021-09-20
Date received
2021-02-12
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
Cheng Zhiwei
Address
# 530, Xida Rd., New District Wuxi CN 214012 214012

FDA Registration Numbers

Source Documents

510(k) summary PDF

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