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510(k) K220059

Device
Biosci? Inactivated Transport Medium, Biosci? ITM
Applicant
Shenzhen Dakewe Bio-Engineering Co., Ltd.
510(k) number
K220059
Product code
QBD
Decision
Substantially Equivalent (SESE)
Decision date
2023-01-19
Date received
2022-01-10
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

Applicant Contact#

Contact
Wei Jiang
Address
#14 Jinhui Rd., Kengzi St., Pingshan District Shenzhen CN 518122 518122

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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