FDA 510(k)

OncoMate MSI Dx Analysis System

K-Number: K200129 · 2021-07-26

Decision Date2021-07-26

Product CodePZJ

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

OncoMate MSI Dx Analysis System is the device name listed in this FDA 510(k) record. The listed applicant is Promega Corporation. It received FDA 510(k) clearance on 2021-07-26 under 510(k) number K200129. The device is classified under product code PZJ. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OncoMate MSI Dx Analysis System?

OncoMate MSI Dx Analysis System is a medical device that received FDA 510(k) clearance on 2021-07-26. The listed applicant is Promega Corporation. The 510(k) number is K200129.

When did OncoMate MSI Dx Analysis System receive FDA 510(k) clearance?

OncoMate MSI Dx Analysis System received FDA 510(k) clearance on 2021-07-26, under 510(k) number K200129.

Who is the listed applicant for OncoMate MSI Dx Analysis System?

The FDA 510(k) record lists Promega Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OncoMate MSI Dx Analysis System?

The FDA product code for OncoMate MSI Dx Analysis System is PZJ.

Other records listing Promega Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMA P240026Nucleic Acid Based Assay, Microsatellite Instability

Related Devices (Code: PZJ)

K211181Idylla MSI TestBiocartis NV K213348BOND MMR Antibody PanelLeica Biosystems Newcastle, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.