510(k) DEN240067
- Device
- KMT2A Breakapart FISH Probe Kit PDx (CDA-LPH013)
- Applicant
- Cytocell Limited
- 510(k) number
- DEN240067
- Product code
- SFS
- Decision
- Unknown (DENG)
- Decision date
- 2025-09-19
- Date received
- 2024-11-22
- Regulation
- 864.1885
- Classification name
- Revumenib Eligibility Detection System
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Steve Chatters
- Address
- Oxford Gene Technology, 418 Cambridge Science Park Milton Rd. Cambridge GB CB4 0PZ CB4 0PZ
FDA Registration Numbers#
- 9710378
- 3011279282
Source Documents#
510(k) summary PDF not indicated by FDA