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

BK230839 - Elecsys Syphilis; PreciControl Syphilis; PreciControl Release Syphilis

510(k) Number: BK230839
Applicant: Roche Diagnostics
Device Name: Elecsys Syphilis
PreciControl Syphilis
PreciControl Release Syphilis
Decision Date: 7/31/2023

Supporting Documents

BK230839 Letter
BK230839 Summary

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