Aptima Combo 2 Assay (Panther) - 250 test kit, Aptima Combo 2 Assay (Tigris) - 250 test kit, Aptima Trichomonas Vaginalis (Panther) - 250 test kit, Aptima Trichomonas Vaginalis (Tigris) - 250 test kit— 510(k) K200436

Name: FDA 510(k) clearance K200436
Creator: U.S. Food and Drug Administration
Published: 2020-03-23

Substantially Equivalent

Hologic, Inc.

FDA 510(k) clearance K200436 for Aptima Combo 2 Assay (Panther) - 250 test kit, Aptima Combo 2 Assay (Tigris) - 250 test kit, Aptima Trichomonas Vaginalis (Panther) - 250 test kit, Aptima Trichomonas Vaginalis (Tigris) - 250 test kit, Substantially Equivalent on 2020-03-23. Applicant: Hologic, Inc.. Device class: 2.

Clearance details

Applicant: Hologic, Inc.
Product code: Code QEP
Device class: Class 2
Regulation: 21 CFR 866.3393
Advisory panel: Microbiology
Date received: 2020-02-24
Decision date: 2020-03-23
Decision: Substantially Equivalent
Clearance type: Special
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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