Cytocell, Ltd. · Class II · Cleared Dec 21, 2018
| K-number | DEN170070 |
| Device name | 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 |
| Applicant | Cytocell, Ltd. |
| Product code | QDI |
| Device class | Class II |
| Decision date | Dec 21, 2018 |
| Decision | Not Substantially Equivalent |
| Regulation | 864.1880 |
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