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cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K240867
510(k) Type
Traditional
Applicant
Roche Molecular Systems, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/11/2025
Days to Decision
319 days
Submission Type
Summary

cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K240867
510(k) Type
Traditional
Applicant
Roche Molecular Systems, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/11/2025
Days to Decision
319 days
Submission Type
Summary