KMT2A Breakapart FISH Probe Kit PDx (CDA-LPH013)— 510(k) DEN240067

Name: FDA 510(k) clearance DEN240067
Creator: U.S. Food and Drug Administration
Published: 2025-09-19

Unknown

Cytocell Limited

FDA 510(k) clearance DEN240067 for KMT2A Breakapart FISH Probe Kit PDx (CDA-LPH013), Unknown on 2025-09-19. Applicant: Cytocell Limited. Device class: 2.

Clearance details

Applicant: Cytocell Limited
Product code: Code SFS
Device class: Class 2
Regulation: 21 CFR 864.1885
Advisory panel: Hematology
Date received: 2024-11-22
Decision date: 2025-09-19
Decision: Unknown
Clearance type: Direct
Location: Cambridge, GB

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