OPTMIZER CTS T-CELL EXPANSION SERUM FREE MEDIUM
FDA 510(k) clearance K113566 · decided 2012-06-21
Clearance details
- K-number
- K113566
- Device name
- OPTMIZER CTS T-CELL EXPANSION SERUM FREE MEDIUM
- Applicant
- Life Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-12-02
- Decision date
- 2012-06-21
- Days to decision
- 202 days
- Clearance type
- Traditional
- Product code
- NDS
- Device class
- 2
- Regulation number
- 876.5885
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Grand Island, NY, US
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
|---|---|---|
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