KMT2A Breakapart FISH Probe Kit PDx (CDA-LPH013)

• K Number: DEN240067
• Device Name: KMT2A Breakapart FISH Probe Kit PDx (CDA-LPH013)
• Manufacturer: Cytocell Limited
• Date Cleared: 2025-09-19 ( 301 days)
• Product Code: SFS
• Regulation Number: 864.1885
• Type: Direct
• Panel: Molecular Genetics
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

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Device Description

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AI/ML Overview

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Summary

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Regulation Number and Section

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