510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K113566Substantially Equivalent

Optmizer Cts T-Cell Expansion Serum Free Medium

Life Technologies Corporation, Grand Island NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K113566 is the FDA 510(k) clearance record for OPTMIZER CTS T-CELL EXPANSION SERUM FREE MEDIUM, a class II device, cleared for Life Technologies, Inc. on under FDA product code NDS (Media, Culture, Ex Vivo, Tissue And Cell). FDA records list 11 510(k) clearances for Life Technologies, Inc., from to . As of , FDA records show one recall naming K113566.

Clearance record

Decision date
Received
(202 days to decision)
Product code
NDS Media, Culture, Ex Vivo, Tissue And Cell
Regulation
21 CFR 876.5885
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Life Technologies, Inc. 3175 Staley Rd., Grand Island NY
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NDS

Trailing 12 months

FDA records hold no clearances under product code NDS in the trailing twelve months.

FDA records show no clearances under product code NDS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NDS, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260