Aptima BV Assay— 510(k) K190452

Substantially Equivalent

Hologic, Inc.

FDA 510(k) clearance K190452 for Aptima BV Assay, Substantially Equivalent on 2019-05-23. Applicant: Hologic, Inc.. Device class: 2.

Clearance details

Applicant: Hologic, Inc.
Product code: Code PQA
Device class: Class 2
Regulation: 21 CFR 866.3975
Advisory panel: Microbiology
Date received: 2019-02-25
Decision date: 2019-05-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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