Last synced on 30 November 2024 at 11:09 am

Aptima Combo 2 Assay (250 test kit) Panther, Aptima Combo 2 Assay (250 test kit) Tigris, Aptima Trichomonas Vaginalis Assay (250 test kit) Panther, Aptima Trichomonas Vaginalis Assay (250 test kit) Tigris

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K220321
510(k) Type
Special
Applicant
Hologic, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/3/2022
Days to Decision
120 days
Submission Type
Summary

Aptima Combo 2 Assay (250 test kit) Panther, Aptima Combo 2 Assay (250 test kit) Tigris, Aptima Trichomonas Vaginalis Assay (250 test kit) Panther, Aptima Trichomonas Vaginalis Assay (250 test kit) Tigris

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K220321
510(k) Type
Special
Applicant
Hologic, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/3/2022
Days to Decision
120 days
Submission Type
Summary