MycoMEIA Aspergillus Assay— 510(k) K243496

Name: FDA 510(k) clearance K243496
Creator: U.S. Food and Drug Administration
Published: 2025-08-01

Substantially Equivalent

Pearl Diagnostics, Inc.

FDA 510(k) clearance K243496 for MycoMEIA Aspergillus Assay, Substantially Equivalent on 2025-08-01. Applicant: Pearl Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Pearl Diagnostics, Inc.
Product code: Code NOM
Device class: Class 1
Regulation: 21 CFR 866.3040
Advisory panel: Microbiology
Date received: 2024-11-12
Decision date: 2025-08-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Baltimore, MD, US

Download summary PDF View on FDA.gov ↗

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K093678 — PLATELIA ASPERGILLUS EIA MODEL 627932011-01-13
K060641 — PLATELIA ASPERGILLUS EIA, MODEL 627932006-06-02
K023857 — PLATELIA ASPERGILLUS EIA, MODELS 62793 AND 627942003-05-16

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