510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
DEN170070Unknown

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

Cytocell Limited, Cambridge, GB / Direct, Unknown
FDA source (opens on fda.gov)

DEN170070 is the FDA 510(k) clearance record 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, a class II device, cleared for Cytocell, Ltd. on under FDA product code QDI (Fish Based Detection Of Chromosomal Abnormalities From Patients With Hematologic Malignancies). FDA's definition for product code QDI reads: "Fluorescence In Situ Hybridization (FISH) Test for Hematologic Malignancies is used to detect chromosomal abnormalities in human specimens from patients with hematologic malignancies. The test is indicated for the clinical management of...". FDA records list 2 510(k) clearances for Cytocell, Ltd., from to . As of , FDA records show no recalls naming DEN170070.

Clearance record

Decision date
Received
(448 days to decision)
Product code
QDI Fish Based Detection Of Chromosomal Abnormalities From Patients With Hematologic Malignancies
Regulation
21 CFR 864.1880
Device class
Class II
Review panel
Medical Genetics
Applicant
Cytocell, Ltd. 3-4 Technopark, Newmarket Rd., Cambridge, GB
Third party review
No

Clearances, product code QDI

Trailing 12 months

FDA records hold no clearances under product code QDI in the trailing twelve months.

FDA records show no clearances under product code QDI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QDI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260