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510(k) K222771

Device
Sample Preservative Fluid
Applicant
Hangzhou Bioer Technology Co., Ltd.
510(k) number
K222771
Product code
QBD
Decision
Substantially Equivalent (SESE)
Decision date
2024-06-26
Date received
2022-09-14
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
Zoey .
Address
1192 Binan Rd. Hangzhou CN 310053 310053

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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