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  1. Substantially Equivalent 510(k) Device Information

BK251233 - cobas HIV-1/HIV-2 Qualitative nucleic acid test for use on the cobas 5800/6800/8800 systems

510(k) Number: BK251233 
Applicant: Roche Molecular Systems, Inc 
Device Name: cobas® HIV-1/HIV-2 Qualitative nucleic acid test for use on the cobas® 5800/6800/8800 systems 
Decision Date: 6/27/2025

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