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  1. Substantially Equivalent 510(k) Device Information

BK251235 - cobas® HIV-1 Quantitative nucleic acid test for use on the cobas® 5800/6800/8800 systems

510(k) Number: BK251235 
Applicant: Roche Molecular Systems, Inc 
Device Name: cobas® HIV-1 Quantitative nucleic acid test for use on the cobas® 5800/6800/8800 systems
Decision Date: 7/1/2025

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