Cleared Traditional

KNOCKOUT SR MEDIUM, KNOCKOUT SR XENOFREE MEDIUM MODEL 10828, 12618

K100616 · Life Technologies Corporation · Gastroenterology & Urology
May 2010
Decision
77d
Days
Class 2
Risk

About This 510(k) Submission

K100616 is an FDA 510(k) clearance for the KNOCKOUT SR MEDIUM, KNOCKOUT SR XENOFREE MEDIUM MODEL 10828, 12618, a Media, Culture, Ex Vivo, Tissue And Cell (Class II — Special Controls, product code NDS), submitted by Life Technologies Corporation (Grand Island, US). The FDA issued a Cleared decision on May 20, 2010, 77 days after receiving the submission on March 4, 2010. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5885.

Submission Details

510(k) Number K100616 FDA.gov
FDA Decision Cleared SESE
Date Received March 04, 2010
Decision Date May 20, 2010
Days to Decision 77 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code NDS — Media, Culture, Ex Vivo, Tissue And Cell
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5885

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