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iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K221802
510(k) Type
Traditional
Applicant
Mawi DNA Technologies
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/3/2023
Days to Decision
286 days
Submission Type
Summary

iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K221802
510(k) Type
Traditional
Applicant
Mawi DNA Technologies
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/3/2023
Days to Decision
286 days
Submission Type
Summary