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

BK180286 - ALBAcyte IgG Sensitized Red Blood Cells II

510(k) Number: BK180286
Applicant: Alba Bioscience Limited
Device Name: ALBAcyte® IgG Sensitized Red Blood Cells II
Decision Date: 2/5/2019

Supporting Documents

BK180286 Letter
The date of the substantially equivalence determination was February 5, 2019.
BK180286 Summary
BK180286 Instructions for Use

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