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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 K100616
Device Name KNOCKOUT SR MEDIUM, KNOCKOUT SR XENOFREE MEDIUM MODEL 10828, 12618
Applicant
Life Technologies Corporation
3175 Staley Rd.
Grand Island,  NY  14072
Applicant Contact KELLI TANZELLA
Correspondent
Life Technologies Corporation
3175 Staley Rd.
Grand Island,  NY  14072
Correspondent Contact KELLI TANZELLA
Regulation Number876.5885
Classification Product Code
NDS  
Date Received03/04/2010
Decision Date 05/20/2010
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
Predetermined Change
Control Plan Authorized		 No
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