510(k) DEN170070 ยท QDI Fish Based Detection Of Chromosomal Abnormalities From Patients With Hematologic Malignancies
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 Ki
| Applicant | Cytocell, Ltd., Cambridge, GB |
| Decision | Unknown, Dec 21, 2018 |
| Received | Sep 29, 2017 |
| Type | Direct |
| FDA record | Open on fda.gov |
Recalls that name DEN170070
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.