K243496
- 510(k) number
- K243496
- Device name
- MycoMEIA Aspergillus Assay
- Applicant
- Pearl Diagnostics, Inc. MD · US
- Product code
- NOM — Antigen, Galactomannan, Aspergillus Spp.
- Decision date
- 2025-08-01
- Date received
- 2024-11-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
510(k) Summary (official FDA PDF): K243496.pdf
Official FDA record: K243496
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.