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cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K243400
510(k) Type
Dual Track
Applicant
Roche Molecular Systems, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/25/2025
Days to Decision
176 days
Submission Type
Summary

cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K243400
510(k) Type
Dual Track
Applicant
Roche Molecular Systems, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/25/2025
Days to Decision
176 days
Submission Type
Summary