FDA 510(k) clearance · back to tracker

MycoMEIA Aspergillus Assay

Pearl Diagnostics, Inc. cleared K243496 on 2025-08-01, decision: substantially equivalent

K-number

K243496

Sponsor

Pearl Diagnostics, Inc.

Device

MycoMEIA Aspergillus Assay

Class

Class I

Decision

Substantially Equivalent

Decision date

2025-08-01

Product code

NOM

Advisory committee

Microbiology

Medical specialty

Microbiology

Regulation number

866.3040

Official FDA record

Open K243496on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

openFDA JSON

Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.