Panther Fusion GI Bacterial Assay— 510(k) K251868

Substantially Equivalent

Hologic

FDA 510(k) clearance K251868 for Panther Fusion GI Bacterial Assay, Substantially Equivalent on 2025-09-25. Applicant: Hologic.

Clearance details

Applicant: Hologic
Product code: Code PCH
Advisory panel: Microbiology
Date received: 2025-06-18
Decision date: 2025-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

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