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K Number
DEN240025
Device Name
VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail (08507023001)
Manufacturer
Ventana Medical Systems, Inc.
Date Cleared
2024-12-05
(190 days)
Product Code
SDP
Regulation Number
864.1861
Type
Direct
Panel
PA
Reference & Predicate Devices
N/A
AI/ML
SaMD
IVD (In Vitro Diagnostic)
Therapeutic
Diagnostic
is PCCP Authorized
Thirdparty
Expeditedreview
Intended Use
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Device Description
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AI/ML Overview
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Summary
Regulation Number and Section
N/A
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