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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 severe combined immunodeficiency disorder (scid) newborn screening test system
De Novo Number DEN140010
Device Name PERKINELMER ENLITE NEONATAL TREC TEST SYSTEM
Requester
WALLAC OY
940 winter street
waltham,  MA  02451
Contact kay a taylor
Regulation Number866.5930
Classification Product Code
PJI  
Date Received02/19/2014
Decision Date 12/15/2014
Decision granted (DENG)
Classification Advisory Committee Immunology
Review Advisory Committee Pathology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct
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