Alinity m EBV (09N43-095)— 510(k) K243489

Substantially Equivalent

Abbott Molecular, Inc.

FDA 510(k) clearance K243489 for Alinity m EBV (09N43-095), Substantially Equivalent on 2025-07-28. Applicant: Abbott Molecular, Inc..

Clearance details

Applicant: Abbott Molecular, Inc.
Product code: Code QLX
Advisory panel: Microbiology
Date received: 2024-11-12
Decision date: 2025-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Des Plaines, IL, US

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