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FDA 510(k)

MycoMEIA Aspergillus Assay

K-Number: K243496 · 2025-08-01

ApplicantPearl Diagnostics, Inc.
Decision Date2025-08-01
Product CodeNOM
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MycoMEIA Aspergillus Assay is a medical device manufactured by Pearl Diagnostics, Inc.. It received FDA 510(k) clearance on 2025-08-01 under approval number K243496. The device is classified under product code NOM. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MycoMEIA Aspergillus Assay?

MycoMEIA Aspergillus Assay is a medical device that received FDA 510(k) clearance on 2025-08-01. It is manufactured by Pearl Diagnostics, Inc.. The 510(k) number is K243496.

When was MycoMEIA Aspergillus Assay approved by the FDA?

MycoMEIA Aspergillus Assay received FDA 510(k) clearance on 2025-08-01, under approval number K243496.

What company makes MycoMEIA Aspergillus Assay?

MycoMEIA Aspergillus Assay is manufactured by Pearl Diagnostics, Inc..

What is the FDA product code for MycoMEIA Aspergillus Assay?

The FDA product code for MycoMEIA Aspergillus Assay is NOM.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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