510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K200129Substantially Equivalent

OncoMate MSI Dx Analysis System

Promega Corporation, Madison WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K200129 is the FDA 510(k) clearance record for OncoMate MSI Dx Analysis System, a class II device, cleared for Promega Corporation 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 one 510(k) clearance for Promega Corporation. As of , FDA records show no recalls naming K200129.

Clearance record

Decision date
Received
(552 days to decision)
Product code
PZJ Lynch Syndrome Test System
Regulation
21 CFR 864.1866
Device class
Class II
Review panel
Immunology
Applicant
Promega Corporation 2800 Woods Hollow Rd., Madison WI
510(k) summary
Summary PDF
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