510(k) DEN170070

Device

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.

510(k) number

DEN170070

Product code

QDI

Decision

Unknown (DENG)

Decision date

2018-12-21

Date received

2017-09-29

Regulation

864.1880

Classification name

Fish Based Detection Of Chromosomal Abnormalities From Patients With Hematologic Malignancies

Medical specialty

Medical Genetics

Review panel

Medical Genetics

Device class

2

Clearance type

Direct

Third party reviewed

N