OPTMIZER CTS T-CELL EXPANSION SERUM FREE MEDIUM— 510(k) K113566

Name: FDA 510(k) clearance K113566
Creator: U.S. Food and Drug Administration
Published: 2012-06-21

Substantially Equivalent

Life Technologies, Inc.

FDA 510(k) clearance K113566 for OPTMIZER CTS T-CELL EXPANSION SERUM FREE MEDIUM, Substantially Equivalent on 2012-06-21. Applicant: Life Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Life Technologies, Inc.
Product code: Code NDS
Device class: Class 2
Regulation: 21 CFR 876.5885
Advisory panel: Gastroenterology, Urology
Date received: 2011-12-02
Decision date: 2012-06-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Grand Island, NY, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K113566

K-number listed on FDA's recall record

Z-2542-2018 — Gibco CTS OpTmizer T Cell Expansion Serum Free Medium, bag format, Model Numbers A1048503 and A1022103. Tissue and cell culture medium.Class II·Terminated·Life Technologies, Corp.·20180510

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K113566.

Data sourced from openFDA. This site is unofficial and independent of the FDA.