FDA Product Code
FDA Product Code QDI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Medical Genetics
- 21 CFR Citation
- 864.1880
510(k) Clearances — 1 record
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| DEN170070 | MLL (KMT2A) Breakapart FISH Probe Kit; AML1 (RUNX1) Breakapart FISH Probe Kit, P53 (TP53) Deletion FISH Probe Kit; EVI1 (MECOM) Breakapart FISH Probe Kit, Del(20q) Deletion FISH Probe Kit; AML1/ETO (RUNX1/RUNXIT1)) Translocation, Dual Fusi, CBFB (CBFB) /MYH11 Translocation, Dual Fusion FISH Probe Kit,Del(5q)Deletion FISH Probe Kit; Del(7q)Deletion FISH Probe Kit | Cytocell, Ltd. | 2018-12-21 | Direct | — |
Product code QDI · Class II · Medical Genetics. Data: openFDA.