NP Screen

Device To Detect Or Measure Nucleic Acid From Viruses Associated With Head And Neck Cancers

Advance Sentry Corporation

The following data is part of a De Novo classification by Advance Sentry Corporation with the FDA for Np Screen.

Pre-market Notification Details

DeNovo IDDEN190031
Device Name:NP Screen
ClassificationDevice To Detect Or Measure Nucleic Acid From Viruses Associated With Head And Neck Cancers
Applicant Advance Sentry Corporation 7155 Woodbine Avenue, Suite 202 Markham,  CA L3r 1a3
ContactLeo Chui
Product CodeOJY  
CFR Regulation Number866.3236 [🔎]
DecisionGranted (DENG)
510(k) Premarket NotificationDevice Classification Under Section 513(f)(2)(De Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin
Review Advisory BoardMicrobiology
Classification AdvisoryMicrobiology
TypeDirect
Date Received2019-06-24
Decision Date2020-05-11
Reclassification Order:Reclassification Order

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