K243345

Substantially Equivalent

Aptima BV Assay; Aptima CV/TV Assay

Applicant: Hologic, Inc.
Product code: PQA
Advisory panel: Microbiology
Date received: 2024-10-28
Decision date: 2024-11-25
Decision: Substantially Equivalent
Clearance type: Special
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.