Aptima CV/TV Assay— 510(k) K190472

Substantially Equivalent

Hologic, Inc.

FDA 510(k) clearance K190472 for Aptima CV/TV Assay, Substantially Equivalent on 2019-05-16. Applicant: Hologic, Inc..

Clearance details

Applicant: Hologic, Inc.
Product code: Code PQA
Advisory panel: Microbiology
Date received: 2019-02-26
Decision date: 2019-05-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

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