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Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K241240
510(k) Type
Traditional
Applicant
Hologic, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/18/2024
Days to Decision
76 days
Submission Type
Summary

Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K241240
510(k) Type
Traditional
Applicant
Hologic, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/18/2024
Days to Decision
76 days
Submission Type
Summary