MycoMEIA Aspergillus Assay— 510(k) K243496

Substantially Equivalent

Pearl Diagnostics, Inc.

FDA 510(k) clearance K243496 for MycoMEIA Aspergillus Assay, Substantially Equivalent on 2025-08-01. Applicant: Pearl Diagnostics, Inc..

Clearance details

Applicant: Pearl Diagnostics, Inc.
Product code: Code NOM
Advisory panel: Microbiology
Date received: 2024-11-12
Decision date: 2025-08-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Baltimore, MD, US

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