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Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K200866
510(k) Type
Special
Applicant
Hologic, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/17/2020
Days to Decision
46 days
Submission Type
Summary

Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K200866
510(k) Type
Special
Applicant
Hologic, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/17/2020
Days to Decision
46 days
Submission Type
Summary