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

DEN240025 Class II Direct
Decision Date
2024-12-05
Sponsor / Applicant
Ventana Medical Systems, Inc.

Technical Specification

510(k) Submission ID DEN240025
Product Code SDP
Medical Specialty / Panel Hematology
Regulation Citation 21 CFR 864.1861
Decision Date 2024-12-05
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

VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail (08507023001) received FDA 510(k) clearance under submission number DEN240025, sponsored by Ventana Medical Systems, Inc.. The device was reviewed via the Direct premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2024-12-05.

Classification & Regulation

This clearance is catalogued under FDA product code SDP and 21 CFR 864.1861, within the Hematology review panel as a Class II device.