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KMT2A Breakapart FISH Probe Kit PDx (CDA-LPH013)

DEN240067 Class II Direct
Decision Date
2025-09-19
Sponsor / Applicant
Cytocell Limited

Technical Specification

510(k) Submission ID DEN240067
Product Code SFS
Medical Specialty / Panel Hematology
Regulation Citation 21 CFR 864.1885
Decision Date 2025-09-19
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

KMT2A Breakapart FISH Probe Kit PDx (CDA-LPH013) received FDA 510(k) clearance under submission number DEN240067, sponsored by Cytocell Limited. The device was reviewed via the Direct premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2025-09-19.

Classification & Regulation

This clearance is catalogued under FDA product code SFS and 21 CFR 864.1885, within the Hematology review panel as a Class II device.