K200866

Substantially Equivalent

Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System)

Applicant: Hologic, Inc.
Product code: QEP
Advisory panel: Microbiology
Date received: 2020-04-01
Decision date: 2020-05-17
Decision: Substantially Equivalent
Clearance type: Special
Location: San Diego, CA, US

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