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  1. Substantially Equivalent 510(k) Device Information

BK251234 - Alinity m HIV-1 AMP Kit; Alinity m HIV-1 CTRL Kit; Alinity m HIV-1 CAL Kit; Alinity m HIV-1 Application Specification File

510(k) Number: BK251234
Applicant: Abbott Molecular
Device Name: Alinity m HIV-1 AMP Kit; Alinity m HIV-1 CTRL Kit; Alinity m HIV-1 CAL Kit; Alinity m HIV-1 Application Specification File
Decision Date: 8/27/2025

Supporting Documents

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