KMT2A Breakapart FISH Probe Kit PDx (CDA-LPH013)
FDA 510(k) clearance DEN240067 · decided 2025-09-19
Clearance details
- K-number
- DEN240067
- Device name
- KMT2A Breakapart FISH Probe Kit PDx (CDA-LPH013)
- Applicant
- Cytocell Limited
- Decision
- Unknown
- Date received
- 2024-11-22
- Decision date
- 2025-09-19
- Days to decision
- 301 days
- Clearance type
- Direct
- Product code
- SFS
- Device class
- 2
- Regulation number
- 864.1885
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Cambridge, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.