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510(k) K230035

Device
BioSci? Disposable Virus Sampling Tubes
Applicant
Shenzhen Dakewe Bio-Engineering Co., Ltd.
510(k) number
K230035
Product code
JSM
Decision
Substantially Equivalent (SESE)
Decision date
2023-04-05
Date received
2023-01-05
Regulation
866.2390
Classification name
Culture Media, Non-Propagating Transport
Medical specialty
Microbiology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Jiang Wei
Address
Rm. 702-703, Bldg. #1,Shenzhen Biomedicine Innovations Industrial Park, #14 Jinhui Rd., Kengzi St., Pingshan Shenzhen CN 518122 518122

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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K232357Copan Universal Transport Medium (UTM-RT) SystemCopan Italia Spa2024-04-25
K202531Azer Scientific Universal Transport MediumAzer Scientific, Inc.2024-04-11
K231843ARX Viral Transport Media Collection and Transport SystemArx Sciences, Inc.2024-03-19
K231027KaiBiLi Extended ViralTransHangzhou Genesis Biodetection & Biocontrol Co., Ltd.2023-12-21
K212743MedSchenker Smart Transport Medium (STM15-A/STM20-A/STM30-A/SCS30-A) SystemMedschenker, Inc.2023-05-03
K220052Copan FecalSwab Collection, Transport and Preservation SystemCopan Italia Spa2022-12-16