CINtec Histology (50 tests), CINtec Histology (250 tests)— 510(k) DEN160019

Name: FDA 510(k) clearance DEN160019
Creator: U.S. Food and Drug Administration
Published: 2017-03-04

Unknown

Ventana Medical Systems, Inc.

FDA 510(k) clearance DEN160019 for CINtec Histology (50 tests), CINtec Histology (250 tests), Unknown on 2017-03-04. 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: 2016-05-23
Decision date: 2017-03-04
Decision: Unknown
Clearance type: Direct
Location: Tucson, AZ, US

View on FDA.gov ↗

Recent devices under product code PRB

view all

K212176 — CINtec Histology2021-12-10

More clearances from Ventana Medical Systems, Inc.

view all

K242783 — Roche Digital Pathology Dx2024-12-17
DEN240025 — VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail (08507023001)2024-12-05
K232879 — Roche Digital Pathology Dx (VENTANA DP 200)2024-06-14
K172471 — VENTANA CD30 (Ber-H2) RxDx Assay2018-05-08
K142965 — Virtuoso System for IHC PR (1E2) using iScan HT2015-07-16

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