Aptima SARS-CoV-2 Assay— 510(k) K243396

Substantially Equivalent

Hologic, Inc.

FDA 510(k) clearance K243396 for Aptima SARS-CoV-2 Assay, Substantially Equivalent on 2025-02-13. Applicant: Hologic, Inc..

Clearance details

Applicant: Hologic, Inc.
Product code: Code QQX
Advisory panel: Microbiology
Date received: 2024-10-31
Decision date: 2025-02-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

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