Last synced on 6 December 2024 at 11:05 pm

Xpert® Xpress CoV-2 plus

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K230440
510(k) Type
Traditional
Applicant
Cepheid®
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/13/2023
Days to Decision
234 days
Submission Type
Summary

Xpert® Xpress CoV-2 plus

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K230440
510(k) Type
Traditional
Applicant
Cepheid®
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/13/2023
Days to Decision
234 days
Submission Type
Summary