Aptima Combo 2 Assay (Panther System)— 510(k) K180681

Substantially Equivalent

Hologic, Inc.

FDA 510(k) clearance K180681 for Aptima Combo 2 Assay (Panther System), Substantially Equivalent on 2018-06-13. Applicant: Hologic, Inc..

Clearance details

Applicant: Hologic, Inc.
Product code: Code LSL
Advisory panel: Microbiology
Date received: 2018-03-15
Decision date: 2018-06-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

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