Alinity m CMV— 510(k) K243485

Substantially Equivalent

Abbott Molecular, Inc.

FDA 510(k) clearance K243485 for Alinity m CMV, Substantially Equivalent on 2025-07-01. Applicant: Abbott Molecular, Inc.. Device class: 2.

Clearance details

Applicant
Abbott Molecular, Inc.
Product code
Code PAB
Device class
Class 2
Regulation
21 CFR 866.3180
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Des Plaines, IL, US
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