K231804
- 510(k) number
- K231804
- Device name
- PRIME-XV FreezIS DMSO-Free MD
- Applicant
- Fujifilm Irvine Scientific CA · US
- Product code
- NDS — Media, Culture, Ex Vivo, Tissue And Cell
- Decision date
- 2023-11-09
- Date received
- 2023-06-20
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K231804.pdf
Official FDA record: K231804
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.