FDA Product Code
FDA Product Code SFS — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.1885
510(k) Clearances — 1 record
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| DEN240067 | KMT2A Breakapart FISH Probe Kit PDx (CDA-LPH013) | Cytocell Limited | 2025-09-19 | Direct | — |
Product code SFS · Class II · Hematology. Data: openFDA.