OncoMate MSI Dx Analysis System
K-Number: K200129 · 2021-07-26
ApplicantPromega Corporation
Decision Date2021-07-26
Product CodePZJ
Advisory CommitteeIM
DecisionSubstantially Equivalent
Device Summary
OncoMate MSI Dx Analysis System is a medical device manufactured by Promega Corporation. It received FDA 510(k) clearance on 2021-07-26 under approval 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. It is manufactured by Promega Corporation. The 510(k) number is K200129.
When was OncoMate MSI Dx Analysis System approved by the FDA?
OncoMate MSI Dx Analysis System received FDA 510(k) clearance on 2021-07-26, under approval number K200129.
What company makes OncoMate MSI Dx Analysis System?
OncoMate MSI Dx Analysis System is manufactured by Promega Corporation.
What is the FDA product code for OncoMate MSI Dx Analysis System?
The FDA product code for OncoMate MSI Dx Analysis System is PZJ.
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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.