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Simplexa COVID-19 & Flu A/B Direct

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K220963
510(k) Type
Traditional
Applicant
DiaSorin Molecular LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/17/2023
Days to Decision
350 days
Submission Type
Summary

Simplexa COVID-19 & Flu A/B Direct

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K220963
510(k) Type
Traditional
Applicant
DiaSorin Molecular LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/17/2023
Days to Decision
350 days
Submission Type
Summary