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— 510(k) DEN170070
UnknownCytocell, Ltd.
FDA 510(k) clearance DEN170070 for 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, Unknown on 2018-12-21. Applicant: Cytocell, Ltd.. Device class: 2.
Clearance details
- Applicant
- Cytocell, Ltd.
- Product code
- Code QDI
- Device class
- Class 2
- Regulation
- 21 CFR 864.1880
- Advisory panel
- Medical Genetics
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Direct
- Location
- Cambridge, GB
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