CINtec Histology— 510(k) K212176

Substantially Equivalent

Ventana Medical Systems, Inc.

FDA 510(k) clearance K212176 for CINtec Histology, Substantially Equivalent on 2021-12-10. Applicant: Ventana Medical Systems, Inc.. Device class: 2.

Clearance details

Applicant: Ventana Medical Systems, Inc.
Product code: Code PRB
Device class: Class 2
Regulation: 21 CFR 864.1865
Advisory panel: Pathology
Date received: 2021-07-12
Decision date: 2021-12-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tucson, AZ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PRB

DEN160019 — CINtec Histology (50 tests), CINtec Histology (250 tests)2017-03-04

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Data sourced from openFDA. This site is unofficial and independent of the FDA.