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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Device ID CORE XT
Classification Namemolecular erythrocyte typing test
Generic Namemolecular erythrocyte typing test
Applicant
Progenika Biopharma, S.A.
ibaizabal bidea, edificio 504 parque technologico de bizkaia
Derio, Bizkaia 
spain  48160
PMA NumberBP170154
Date Received12/01/2017
Decision Date10/11/2018
Decision Approved
Product Code
PEP[ Registered Establishments with PEP ]
Advisory Committee Hematology
Expedited Review Granted? No
Third Party Review Elligble? No
Combination ProductNo
Supplements: S002 S003 S005 S006 S010 S011 S012 S013 S015 
S016 S017 S018 S020 S023 S027 S028 S029 S031 
S033 S039 S044 S052 S053 
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