Last synced on 27 June 2025 at 11:06 pm

Xpert® Xpress CoV-2 plus (XPRS-COV2-10)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K242109
510(k) Type
Dual Track
Applicant
Cepheid®
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/15/2025
Days to Decision
180 days
Submission Type
Summary

Xpert® Xpress CoV-2 plus (XPRS-COV2-10)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K242109
510(k) Type
Dual Track
Applicant
Cepheid®
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/15/2025
Days to Decision
180 days
Submission Type
Summary