K100616 is an FDA 510(k) clearance for the KNOCKOUT SR MEDIUM, KNOCKOUT SR XENOFREE MEDIUM MODEL 10828, 12618. This device is classified as 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 FDA review panel. Regulated under 21 CFR 876.5885.
| 510(k) Number | K100616 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| Product Code | NDS - Media, Culture, Ex Vivo, Tissue And Cell |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5885 |