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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 neurologic disease risk assessment molecular test
De Novo Number DEN240032
Device Name APO-Easy Genotyping kit
Requester
firalis sa
35 rue du fort
huningue,  FR 68330
Contact huseyin firat
Regulation Number866.5850
Classification Product Code
SFC  
Date Received06/21/2024
Decision Date 06/12/2025
Decision granted (DENG)
Classification Advisory Committee Immunology
Review Advisory Committee Immunology
Classification Order Classification Order
Type Direct
Predetermined Change
Control Plan Authorized		 No
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