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U.S. Department of Health and Human Services

510(k) Premarket Notification
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New Search Biologics Clearance Letters and 510(k) Summaries Back To Search Results
Device Classification Name quality control for molecular immunohematology tests
510(k) Number BK130050
Tradename BeadCheck HEA Positive Control
Device Name Quality Control for Molecular Immunohematology Tests
Original Applicant
BioArray Solutions, Ltd.
35 technology drive
suite 100
warren,  NJ  07059
Regulation Number864.9650
Classification Product Code
PFK  
Date Received09/19/2013
Decision Date 05/21/2014
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Pathology
Type 510(k) Abbreviated
Total Product Life Cycle (TPLC) TPLC Device Report
Reviewed by Third Party No
Expedited Review No
Combination Product No
In Vitro Product Yes
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