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Aptima Combo 2 Assay (Panther System)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K190515
510(k) Type
Traditional
Applicant
Hologic, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/23/2019
Days to Decision
83 days
Submission Type
Summary

Aptima Combo 2 Assay (Panther System)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K190515
510(k) Type
Traditional
Applicant
Hologic, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/23/2019
Days to Decision
83 days
Submission Type
Summary