510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
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DEN170030Unknown

VENTANA anti-MLH-1(M1) Mouse Monoclonal Primary Antibody, VENTANA anti-PMS2 (A16-4) Mouse Monoclonal Primary Antibody, VENTANA anti-MSH2 (G219-1129) Mouse Monoclonal Primary Antibody, VENTANA anti-MSH6 (SP 93) Mouse Monoclonal Primary Antibody, VENTANA anti-BRAF V600E (VE1) Mouse Monoclonal Primary Antibody

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

DEN170030 is the FDA 510(k) clearance record for VENTANA anti-MLH-1(M1) Mouse Monoclonal Primary Antibody, VENTANA anti-PMS2 (A16-4) Mouse Monoclonal Primary Antibody, VENTANA anti-MSH2 (G219-1129) Mouse Monoclonal Primary Antibody, VENTANA anti-MSH6 (SP 93) Mouse Monoclonal Primary Antibody, VENTANA anti-BRAF V600E (VE1) Mouse Monoclonal Primary Antibody, a class II device, cleared for Ventana Medical Systems on under FDA product code PZJ (Lynch Syndrome Test System). FDA's definition for product code PZJ reads: "The Lynch syndrome test system is used to identify loss of DNA mismatch repair proteins or microsatellite instability in tumor tissue from cancer patients for the purpose of identifying patients who may benefit from additional testing for...". FDA records list 49 510(k) clearances for Ventana Medical Systems, from to . As of , FDA records show no recalls naming DEN170030.

Clearance record

Decision date
Received
(150 days to decision)
Product code
PZJ Lynch Syndrome Test System
Regulation
21 CFR 864.1866
Device class
Class II
Review panel
Immunology
Applicant
Ventana Medical Systems 1910 E. Innovation Park Dr., Tucson AZ
Third party review
No

Clearances, product code PZJ

Trailing 12 months

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

FDA records show no clearances under product code PZJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PZJ, 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