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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name quality control for molecular immunohematology tests
510(k) Number BK170092
Tradename ID CORE CONTROL
Device Name Quality Control for Molecular Immunohematology Tests
Original Applicant
Progenika Biopharma, S.A.
ibaizabal bidea, edificio 504
parque technologico de bizkaia
derio, bizkaia,  Spain,  48160, 
Regulation Number864.9650
Classification Product Code
PFK  
Date Received08/09/2017
Decision Date 10/11/2018
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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