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In this section: Substantially Equivalent 510(k) Device Information

BK231015 - Reveal G4 Rapid HIV-1/2 Antibody Test

510(k) Number: BK231015
Applicant: MedMira Laboratories, Inc.
Device Name: Reveal® G4 Rapid HIV-1/2 Antibody Test
Decision Date: 12/13/2023

Supporting Documents

BK231015 Letter
BK231015 Summary

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