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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 muscular dystrophy newborn screening test
De Novo Number DEN180056
Device Name GSP Neonatal Creatine Kinase - MM kit
Requester
perkinelmer inc.
940 winter street
waltham,  MA  02451
Contact brian ciccariello
Regulation Number862.1506
Classification Product Code
QJE  
Date Received10/11/2018
Decision Date 12/12/2019
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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