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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
K231306
510(k) Type
Special
Applicant
Roche Molecular Systems, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/1/2023
Days to Decision
27 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
K231306
510(k) Type
Special
Applicant
Roche Molecular Systems, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/1/2023
Days to Decision
27 days
Submission Type
Summary