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Acucy® Influenza A&B Test with the Acucy® 2 System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K241188
510(k) Type
Dual Track
Applicant
Sekisui Diagnostics, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/18/2025
Days to Decision
354 days
Submission Type
Summary

Acucy® Influenza A&B Test with the Acucy® 2 System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K241188
510(k) Type
Dual Track
Applicant
Sekisui Diagnostics, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/18/2025
Days to Decision
354 days
Submission Type
Summary