Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System)— 510(k) K200866

Name: FDA 510(k) clearance K200866
Creator: U.S. Food and Drug Administration
Published: 2020-05-17

Substantially Equivalent

Hologic, Inc.

FDA 510(k) clearance K200866 for Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System), Substantially Equivalent on 2020-05-17. 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: 2020-04-01
Decision date: 2020-05-17
Decision: Substantially Equivalent
Clearance type: Special
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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