Home / 510(k) Clearances / DEN000008

510(k) DEN000008

DULBECCO'S MODIFIED EAGLE MEDIUM (DMEM) by Life Technologies, Inc. — Product Code NDS

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
February 16, 2001
Date Received
December 19, 2000
Clearance Type
Post-NSE
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 by Life Technologies, Inc.

  • K113566 — OPTMIZER CTS T-CELL EXPANSION SERUM FREE MEDIUM (June 21, 2012)
  • K953719 — HUMAN TUBAL FLUID (November 6, 1995)
  • K951835 — MODIFIED HUMAN TUBAL FLUID (MHTF) WITH/WITHOUT PENICILLIN G DOLIUM, WITH/WITHOUT (August 11, 1995)

Other clearances for product code NDS

  • K232543 — MSC SFM (September 6, 2024)
  • 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)