Name: Predicase
Price: 199 USD

K-number	DEN240025
Device name	VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail (08507023001)
Applicant	Ventana Medical Systems, Inc.
Product code	SDP
Device class	Class II
Decision date	Dec 5, 2024
Decision	Not Substantially Equivalent
Regulation	864.1861

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail (08507023001)

Everything you need for a 510(k) submission. Nothing you don't.