Medical Device Manufacturer · GB , Cambridge

Cytocell, Ltd.

1 submissions · 0 cleared · Since 2018

Total

Cleared

Denied

Cytocell, Ltd. — FDA 510(k) Submissions

Cytocell, Ltd. has submitted 1 FDA 510(k) premarket notifications since 2018, of which 0 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Fish Based Detection Of Chromosomal Abnormalities From Patients With Hematologic Malignancies . Use the specialty filter in the sidebar to narrow results.

1 devices

1–1 of 1

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

DEN170070 · QDI Fish Based Detection Of... · Medical Genetics

Dec 2018 448d

Cytocell, Ltd.

Cytocell, Ltd. — FDA 510(k) Submissions

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