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Xpert Xpress CoV-2/Flu/RSV plus

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K231481
510(k) Type
Traditional
Applicant
Cepheid®
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/17/2023
Days to Decision
86 days
Submission Type
Summary

Xpert Xpress CoV-2/Flu/RSV plus

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K231481
510(k) Type
Traditional
Applicant
Cepheid®
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/17/2023
Days to Decision
86 days
Submission Type
Summary