Panels › Medical Genetics › Product code QDI · Class 2
Fish Based Detection Of Chromosomal Abnormalities From Patients With Hematologic Malignancies
Regulation 864.1880
0510(k)s in 12 months (1 all time)
0recalls in 12 months (1 all time)
0recalls that name a 510(k)
Top companies in QDI
| Company | 510(k)s | Recalls |
|---|---|---|
| Cytocell, Ltd. | 1 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 21, 2018 | DEN170070 | MLL (KMT2A) Breakapart FISH Probe Kit; AML1 (RUNX1) Breakapart FISH Probe Kit, P53 (TP53) Deletion FISH Probe Kit; EVI1 Cytocell, Ltd., GB | QDI |
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