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

BK190389 - ALBAcheck BGS Monoclonal Control

510(k) Number: BK190389
Applicant: Alba Bioscience Limited
Device Name: ALBAcheck® BGS Monoclonal Control
Decision Date: 11/26/2019

Supporting Documents

BK190389 Letter
BK190389 Summary
BK190389 Package Insert

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