510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN160019Unknown

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

Ventana Medical Systems Inc, Tucson AZ / Direct, Unknown
FDA source (opens on fda.gov)

DEN160019 is the FDA 510(k) clearance record for CINtec Histology (50 tests), CINtec Histology (250 tests), a class II device, cleared for Ventana Medical Systems, Inc. on under FDA product code PRB (Cervical Intraepithelial Neoplasia (Cin) Test System). FDA's definition for product code PRB reads: "The p16 CIN test system is a qualitative immunohistochemistry (IHC) test to assess the p16INK4a protein in formalin-fixed, paraffin-embedded (FFPE) cervical punch biopsy tissues. It is indicated as an adjunct to examination of hematoxylin...". FDA records list 49 510(k) clearances for Ventana Medical Systems, Inc., from to . As of , FDA records show no recalls naming DEN160019.

Clearance record

Decision date
Received
(285 days to decision)
Product code
PRB Cervical Intraepithelial Neoplasia (Cin) Test System
Regulation
21 CFR 864.1865
Device class
Class II
Review panel
Pathology
Applicant
Ventana Medical Systems, Inc. 1910 E. Innovation Park Dr., Tucson AZ
Third party review
No

Clearances, product code PRB

Trailing 12 months

FDA records hold no clearances under product code PRB in the trailing twelve months.

FDA records show no clearances under product code PRB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PRB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260