Aptima Combo 2 Assay (Panther System)— 510(k) K190515

Substantially Equivalent

Hologic, Inc.

FDA 510(k) clearance K190515 for Aptima Combo 2 Assay (Panther System), Substantially Equivalent on 2019-05-23. Applicant: Hologic, Inc..

Clearance details

Applicant: Hologic, Inc.
Product code: Code QEP
Advisory panel: Microbiology
Date received: 2019-03-01
Decision date: 2019-05-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

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