510(k) K232543

MSC SFM by Yocon Biology Technology Company — Product Code NDS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 6, 2024
Date Received
August 22, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Media, Culture, Ex Vivo, Tissue And Cell
Device Class
Class II
Regulation Number
876.5885
Review Panel
GU
Submission Type