Source document or public record
FDA 510(k) K192063 — PGDx elio tissue complete
FDA 510(k) index record K192063. Device: PGDx elio tissue complete. Applicant as listed: Personal Genome Diagnostics. Decision date: 2020-04-24.
Source
"device_name": "PGDx elio tissue complete"
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 K192063.
Device name: PGDx elio tissue complete. Applicant as listed: Personal Genome Diagnostics.
Decision date: 2020-04-24. Decision wording: Substantially Equivalent.
Product code: PZM. Regulation: 21 CFR 866.6080. Medical specialty: Pathology.
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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