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510(k) K232543

MSC SFM by Yocon Biology Technology Company — Product Code NDS

K232543 is an FDA 510(k) premarket notification submitted by Yocon Biology Technology Company for the device "MSC SFM". The FDA issued a decision of Substantially Equivalent on September 6, 2024. The device falls under product code NDS (Media, Culture, Ex Vivo, Tissue And Cell), a Class II device regulated under 21 CFR 876.5885.

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

Other clearances for product code NDS

  • K240247 — “MoFi” Cell Culture Basal Medium (July 12, 2024)
  • K231804 — PRIME-XV FreezIS DMSO-Free MD (November 9, 2023)
  • K201789 — CT-STOR (September 20, 2021)
  • K113566 — OPTMIZER CTS T-CELL EXPANSION SERUM FREE MEDIUM (June 21, 2012)
  • K103302 — STEMPRO MSC SFM (February 18, 2011)
  • K100616 — KNOCKOUT SR MEDIUM, KNOCKOUT SR XENOFREE MEDIUM MODEL 10828, 12618 (May 20, 2010)
  • K022086 — AIM-V (R) MEDIUM, MODEL 087-0112 (December 23, 2002)
  • DEN000008 — DULBECCO'S MODIFIED EAGLE MEDIUM (DMEM) (February 16, 2001)

FDA data resources