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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 the device name listed in this FDA 510(k) record. The listed applicant is Pearl Diagnostics, Inc.. It received FDA 510(k) clearance on 2025-08-01 under 510(k) 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. The listed applicant is Pearl Diagnostics, Inc.. The 510(k) number is K243496.

When did MycoMEIA Aspergillus Assay receive FDA 510(k) clearance?

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

Who is the listed applicant for MycoMEIA Aspergillus Assay?

The FDA 510(k) record lists Pearl Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

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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