meddevicedb.com FDA Device Reference

CINtec Histology (50 tests), CINtec Histology (250 tests)

DEN160019 Class II Direct
Decision Date
2017-03-04
Sponsor / Applicant
Ventana Medical Systems, Inc.

Technical Specification

510(k) Submission ID DEN160019
Product Code PRB
Medical Specialty / Panel Pathology
Regulation Citation 21 CFR 864.1865
Decision Date 2017-03-04
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

CINtec Histology (50 tests), CINtec Histology (250 tests) received FDA 510(k) clearance under submission number DEN160019, sponsored by Ventana Medical Systems, Inc.. The device was reviewed via the Direct premarket notification pathway and assigned to the Pathology review panel. The statutory decision date of record is 2017-03-04.

Classification & Regulation

This clearance is catalogued under FDA product code PRB and 21 CFR 864.1865, within the Pathology review panel as a Class II device.