MSC SFM
FDA 510(k) clearance K232543 · decided 2024-09-06
Clearance details
- K-number
- K232543
- Device name
- MSC SFM
- Applicant
- Yocon Biology Technology Company
- Decision
- Substantially Equivalent
- Date received
- 2023-08-22
- Decision date
- 2024-09-06
- Days to decision
- 381 days
- Clearance type
- Traditional
- Product code
- NDS
- Device class
- 2
- Regulation number
- 876.5885
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Beijing, CN
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| “MoFi” Cell Culture Basal Medium (K240247) | Duogenic Stemcells Corporation | 2024-07-12 |
| PRIME-XV FreezIS DMSO-Free MD (K231804) | Fujifilm Irvine Scientific | 2023-11-09 |
| CT-STOR (K201789) | Energy Delivery Solutions | 2021-09-20 |
| 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.