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510(k) K100616

KNOCKOUT SR MEDIUM, KNOCKOUT SR XENOFREE MEDIUM MODEL 10828, 12618 by Life Technologies Corporation — Product Code NDS

K100616 is an FDA 510(k) premarket notification submitted by Life Technologies Corporation for the device "KNOCKOUT SR MEDIUM, KNOCKOUT SR XENOFREE MEDIUM MODEL 10828, 12618". The FDA issued a decision of Substantially Equivalent on May 20, 2010. The device falls under product code NDS (Media, Culture, Ex Vivo, Tissue And Cell), a Class II device regulated under 21 CFR 876.5885. Life Technologies Corporation has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 2010
Date Received
March 4, 2010
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 by Life Technologies Corporation

  • K241806 — Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel (January 8, 2025)
  • K233453 — Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Kit (July 10, 2024)
  • K191030 — Applied Biosystems™ 3500 Dx Genetic Analyzer and Applied Biosystems™ 3500xL Dx G (February 21, 2020)
  • K170299 — Ion PGM Dx System (June 22, 2017)
  • K123955 — QUANTSTUDIO DX REAL-TIME PCR INSTRUMENT (March 8, 2013)
  • K103302 — STEMPRO MSC SFM (February 18, 2011)

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)
  • K022086 — AIM-V (R) MEDIUM, MODEL 087-0112 (December 23, 2002)
  • DEN000008 — DULBECCO'S MODIFIED EAGLE MEDIUM (DMEM) (February 16, 2001)

FDA data resources