K162673

Substantially Equivalent

Aptima Herpes Simplex Viruses 1 & 2 Assay

Applicant: Hologic, Inc.
Product code: OQO
Advisory panel: Microbiology
Date received: 2016-09-26
Decision date: 2017-06-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

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