Knockout SR Medium, Knockout SR Xenofree Medium Model 10828, 12618
FDA 510(k) K100616 · Life Technologies Corporation
510(k) numberK100616
Submission
- Device name
- Knockout SR Medium, Knockout SR Xenofree Medium Model 10828, 12618
- Applicant
- Life Technologies Corporation
Grand Island, NY, US - Received
- March 4, 2010
- Decision date
- May 20, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NDS – Media, Culture, Ex Vivo, Tissue And Cell
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5885
- Specialty
- Gastroenterology, Urology
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| K103302 | Stempro MSC SFMNDS · Traditional | Life Technologies Corporation | 02/18/2011SE |
| K022086 | Aim-V (R) Medium, Model 087-0112NDS · Traditional | Invitrogen Corporation | 12/23/2002SE |
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| K113566 | Optmizer CTS T-Cell Expansion Serum Free MediumNDS · Traditional | 06/21/2012SE |
| K103302 | Stempro MSC SFMNDS · Traditional | 02/18/2011SE |
| K953719 | Human Tubal FluidMFD · Traditional | 11/06/1995SE |
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Questions and answers
When was Knockout SR Medium, Knockout SR Xenofree Medium Model 10828, 12618 cleared by the FDA?
Knockout SR Medium, Knockout SR Xenofree Medium Model 10828, 12618 (K100616) received a 510(k) decision of Substantially Equivalent on May 20, 2010, 77 days after the submission was received.
What is the product code of K100616?
The FDA product code is NDS – Media, Culture, Ex Vivo, Tissue And Cell, a Class II (moderate risk) device regulated under 21 CFR 876.5885.