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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 spinal muscular atrophy newborn screening test system
De Novo Number DEN200044
Device Name Eonis SCID-SMA Kit
Requester
perkinelmer, inc.
940 winter st.
waltham,  MA  02451
Contact casey fox
Regulation Number866.5980
Classification Product Code
QUE  
Date Received07/08/2020
Decision Date 11/09/2022
Decision granted (DENG)
Classification Advisory Committee Immunology
Review Advisory Committee Molecular Genetics
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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