510(k) K231804
- Device
- PRIME-XV FreezIS DMSO-Free MD
- Applicant
- Fujifilm Irvine Scientific
- 510(k) number
- K231804
- Product code
- NDS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-11-09
- Date received
- 2023-06-20
- 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
- Abbreviated
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Amanda Cinquin
- Address
- 1830 E. Warner Ave. Santa Ana CA US 92705 92705
FDA Registration Numbers#
- 3016633010
Source Documents#
Other 510(k) Records For Product Code NDS#
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|---|---|---|---|
| K232543 | MSC SFM | Yocon Biology Technology Company | 2024-09-06 |
| K240247 | “MoFi” Cell Culture Basal Medium | Duogenic Stemcells Corporation | 2024-07-12 |
| K201789 | CT-STOR | Energy Delivery Solutions | 2021-09-20 |
| K113566 | OPTMIZER CTS T-CELL EXPANSION SERUM FREE MEDIUM | Life Technologies, Inc. | 2012-06-21 |
| 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 |