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— 510(k) K220321

Substantially Equivalent

Hologic, Inc.

FDA 510(k) clearance K220321 for 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, Substantially Equivalent on 2022-06-03. Applicant: Hologic, Inc..

Clearance details

Applicant: Hologic, Inc.
Product code: Code QEP
Advisory panel: Microbiology
Date received: 2022-02-03
Decision date: 2022-06-03
Decision: Substantially Equivalent
Clearance type: Special
Location: San Diego, CA, US

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