Source document or public record
FDA 510(k) K200129 — OncoMate MSI Dx Analysis System
FDA 510(k) index record K200129. Device: OncoMate MSI Dx Analysis System. Applicant as listed: Promega Corporation. Decision date: 2021-07-26.
Source
"device_name": "OncoMate MSI Dx Analysis System"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
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Automated FDA record verification
2026-10-20
2026-10-20
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FDA 510(k) public index record K200129.
Device name: OncoMate MSI Dx Analysis System. Applicant as listed: Promega Corporation.
Decision date: 2021-07-26. Decision wording: Substantially Equivalent.
Product code: PZJ. Regulation: 21 CFR 864.1866. Medical specialty: Immunology.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
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