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Acucy Influenza A&B Test with the Acucy System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K182001
510(k) Type
Dual Track
Applicant
Sekisui Diagnostics, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/17/2018
Days to Decision
144 days
Submission Type
Summary

Acucy Influenza A&B Test with the Acucy System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K182001
510(k) Type
Dual Track
Applicant
Sekisui Diagnostics, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/17/2018
Days to Decision
144 days
Submission Type
Summary