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510(k) K231027

KaiBiLi Extended ViralTrans by Hangzhou Genesis Biodetection & Biocontrol Co., Ltd. — Product Code JSM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 2023
Date Received
April 11, 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

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