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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name media, culture, ex vivo, tissue and cell
510(k) Number K113566
Device Name OPTMIZER CTS T-CELL EXPANSION SERUM FREE MEDIUM
Applicant
LIFE TECHNOLOGIES, INC.
3175 STALEY RD.
GRAND ISLAND,  NY  14072
Applicant Contact KELLI L TANZELLA
Correspondent
LIFE TECHNOLOGIES, INC.
3175 STALEY RD.
GRAND ISLAND,  NY  14072
Correspondent Contact KELLI L TANZELLA
Regulation Number876.5885
Classification Product Code
NDS  
Date Received12/02/2011
Decision Date 06/21/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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