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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 whole exome sequencing constituent device
De Novo Number DEN190035
Device Name Helix Laboratory Platform
Requester
helix opco, llc
96 colbeck st.
toronto,  CA m6s1 v2
Contact gloria lee
Regulation Number866.6000
Classification Product Code
QNC  
Date Received08/02/2019
Decision Date 12/23/2020
Decision granted (DENG)
Classification Advisory Committee Molecular Genetics
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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