PRIME-XV FreezIS DMSO-Free MD
FDA 510(k) clearance K231804 · decided 2023-11-09
Clearance details
- K-number
- K231804
- Device name
- PRIME-XV FreezIS DMSO-Free MD
- Applicant
- Fujifilm Irvine Scientific
- Decision
- Substantially Equivalent
- Date received
- 2023-06-20
- Decision date
- 2023-11-09
- Days to decision
- 142 days
- Clearance type
- Abbreviated
- Product code
- NDS
- Device class
- 2
- Regulation number
- 876.5885
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Santa Ana, CA, US
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
|---|---|---|
| MSC SFM (K232543) | Yocon Biology Technology Company | 2024-09-06 |
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| OPTMIZER CTS T-CELL EXPANSION SERUM FREE MEDIUM (K113566) | Life Technologies, Inc. | 2012-06-21 |
| STEMPRO MSC SFM (K103302) | Life Technologies Corporation | 2011-02-18 |
| KNOCKOUT SR MEDIUM, KNOCKOUT SR XENOFREE MEDIUM MODEL 10828, 12618 (K100616) | Life Technologies Corporation | 2010-05-20 |
| AIM-V (R) MEDIUM, MODEL 087-0112 (K022086) | Invitrogen Corporation | 2002-12-23 |
| DULBECCO'S MODIFIED EAGLE MEDIUM (DMEM) (DEN000008) | Life Technologies, Inc. | 2001-02-16 |
Recalls involving this device
No recalls on record reference this clearance.