510(k) K113566
- Device
- OPTMIZER CTS T-CELL EXPANSION SERUM FREE MEDIUM
- Applicant
- LIFE TECHNOLOGIES, INC.
- 510(k) number
- K113566
- Product code
- NDS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-06-21
- Date received
- 2011-12-02
- Regulation
- 876.5885
- Classification name
- Media, Culture, Ex Vivo, Tissue And Cell
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- KELLI L TANZELLA
- Address
- 3175 Staley Rd. Grand Island NY US 14072 14072
FDA Registration Numbers#
- 3016633010
Source Documents#
Other 510(k) Records For Product Code NDS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K232543 | MSC SFM | Yocon Biology Technology Company | 2024-09-06 |
| K240247 | “MoFi” Cell Culture Basal Medium | Duogenic Stemcells Corporation | 2024-07-12 |
| K231804 | PRIME-XV FreezIS DMSO-Free MD | Fujifilm Irvine Scientific | 2023-11-09 |
| K201789 | CT-STOR | Energy Delivery Solutions | 2021-09-20 |
| K103302 | STEMPRO MSC SFM | Life Technologies Corporation | 2011-02-18 |
| K100616 | KNOCKOUT SR MEDIUM, KNOCKOUT SR XENOFREE MEDIUM MODEL 10828, 12618 | Life Technologies Corporation | 2010-05-20 |
| K022086 | AIM-V (R) MEDIUM, MODEL 087-0112 | Invitrogen Corporation | 2002-12-23 |
| DEN000008 | DULBECCO'S MODIFIED EAGLE MEDIUM (DMEM) | Life Technologies, Inc. | 2001-02-16 |
Legacy Summary#
summary
FDA Review#
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