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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 software device to aid in the prediction or diagnosis of sepsis
De Novo Number DEN230036
Device Name Sepsis ImmunoScore
Requester
prenosis, inc.
3440 s dearborn st., suite 222s
chicago,  IL  60616
Contact bobby reddy
Regulation Number880.6316
Classification Product Code
SAK  
Date Received05/05/2023
Decision Date 04/02/2024
Decision granted (DENG)
Classification Advisory Committee General Hospital
Review Advisory Committee Gastroenterology/Urology
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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