Aptima BV Assay; Aptima CV/TV Assay— 510(k) K243345

Name: FDA 510(k) clearance K243345
Creator: U.S. Food and Drug Administration
Published: 2024-11-25

Substantially Equivalent

Hologic, Inc.

FDA 510(k) clearance K243345 for Aptima BV Assay; Aptima CV/TV Assay, Substantially Equivalent on 2024-11-25. 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: 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 ↗

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