510(k) K230035

BioSci™ Disposable Virus Sampling Tubes by Shenzhen Dakewe Bio-Engineering Co., Ltd. — Product Code JSM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 2023
Date Received
January 5, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Non-Propagating Transport
Device Class
Class I
Regulation Number
866.2390
Review Panel
MI
Submission Type