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

BK241148 - cobas pro serology solution (applicable to) a) Elecsys Syphilis and b) Elecsys Anti-CMV

510(k) Number: BK241148
Applicant: Roche Diagnostics
Device Name: cobas pro serology solution (applicable to) a) Elecsys Syphilis and b) Elecsys Anti-CMV
Decision Date: 1/10/2025

Supporting Documents

BK241148 Letter
BK241148 Summary

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