Alinity m BKV— 510(k) K241921

Substantially Equivalent

Abbott Molecular, Inc.

FDA 510(k) clearance K241921 for Alinity m BKV, Substantially Equivalent on 2025-03-24. Applicant: Abbott Molecular, Inc..

Clearance details

Applicant: Abbott Molecular, Inc.
Product code: Code QMI
Advisory panel: Microbiology
Date received: 2024-07-01
Decision date: 2025-03-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Des Plaines, IL, US

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