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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 25-oh-vitamin d mass spectrometry test system
De Novo Number DEN170019
Device Name Vitamin D 200M Assay for the Topaz System
Requester
AB SCIEX LLC
500 old connecticut path
framingham,  MA  01701
Contact shilpa sharma
Regulation Number862.1840
Classification Product Code
PSL  
Date Received03/20/2017
Decision Date 05/18/2017
Decision granted (DENG)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Post-NSE
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