510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN240067Unknown

KMT2A Breakapart FISH Probe Kit PDx (CDA-LPH013)

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

DEN240067 is the FDA 510(k) clearance record for KMT2A Breakapart FISH Probe Kit PDx (CDA-LPH013), a class II device, cleared for Cytocell Limited on under FDA product code SFS (Revumenib Eligibility Detection System). FDA's definition for product code SFS reads: "A revumenib eligibility detection system is identified as a prescription in vitro diagnostic device intended for the qualitative detection of structural abnormalities of chromosome 11 in specimens from patients with acute leukemia for the...". FDA records list 2 510(k) clearances for Cytocell Limited, from to . As of , FDA records show no recalls naming DEN240067.

Clearance record

Decision date
Received
(301 days to decision)
Product code
SFS Revumenib Eligibility Detection System
Regulation
21 CFR 864.1885
Device class
Class II
Review panel
Hematology
Applicant
Cytocell Limited Oxford Gene Technology, 418 Cambridge Science Park, Cambridge, GB
Third party review
No

Clearances, product code SFS

Trailing 12 months

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

FDA records show no clearances under product code SFS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code SFS, 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