Source document or public record
FDA 510(k) K243496 — MycoMEIA Aspergillus Assay
FDA 510(k) index record K243496. Device: MycoMEIA Aspergillus Assay. Applicant as listed: Pearl Diagnostics, Inc.. Decision date: 2025-08-01.
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"device_name": "MycoMEIA Aspergillus Assay"
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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2026-10-20
2026-10-20
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FDA 510(k) public index record K243496.
Device name: MycoMEIA Aspergillus Assay. Applicant as listed: Pearl Diagnostics, Inc..
Decision date: 2025-08-01. Decision wording: Substantially Equivalent.
Product code: NOM. Regulation: 21 CFR 866.3040. Medical specialty: Microbiology.
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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