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OraQuick Ebola Rapid Antigen Test

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
DEN190025
510(k) Type
Direct
Applicant
OraSure Technologies, Inc.
Country
United States
FDA Decision
Deleted
Decision Date
10/10/2019
Days to Decision
150 days

OraQuick Ebola Rapid Antigen Test

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
DEN190025
510(k) Type
Direct
Applicant
OraSure Technologies, Inc.
Country
United States
FDA Decision
Deleted
Decision Date
10/10/2019
Days to Decision
150 days