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Found 1 results

510(k) Data Aggregation

K Number

Device Name

MycoMEIA Aspergillus Assay

Manufacturer

Pearl Diagnostics, Inc.

Date Cleared

2025-08-01

(262 days)

Product Code

NOM

Regulation Number

866.3040

Why did this record match?

Applicant Name (Manufacturer) :

Pearl Diagnostics, Inc.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

Device Description

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