Aptima CMV Quant Assay— 510(k) K243935

Substantially Equivalent

Hologic, Inc.

FDA 510(k) clearance K243935 for Aptima CMV Quant Assay, Substantially Equivalent on 2025-01-17. Applicant: Hologic, Inc.. Device class: 2.

Clearance details

Applicant: Hologic, Inc.
Product code: Code PAB
Device class: Class 2
Regulation: 21 CFR 866.3180
Advisory panel: Microbiology
Date received: 2024-12-20
Decision date: 2025-01-17
Decision: Substantially Equivalent
Clearance type: Special
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.