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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name alpha-d-galactosidase a (gla) newborn screening test system
De Novo Number DEN150035
Device Name SEEKER System
Requester
baebies, inc.
615 davis dr.,
p.o. box 14403
durham,  NC  27709
Contact vamsee pamula
Regulation Number862.1488
Classification Product Code
PQW  
Date Received08/05/2015
Decision Date 02/03/2017
Decision granted (DENG)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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