Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay— 510(k) K241240

Substantially Equivalent

Hologic, Inc.

FDA 510(k) clearance K241240 for Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, Substantially Equivalent on 2024-07-18. Applicant: Hologic, Inc..

Clearance details

Applicant
Hologic, Inc.
Product code
Code QOF
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
San Diego, CA, US
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