The following data is part of a De Novo classification by Advance Sentry Corporation with the FDA for Np Screen.
DeNovo ID | DEN190031 |
Device Name: | NP Screen |
Classification | Device 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 |
Contact | Leo Chui |
Product Code | OJY |
CFR Regulation Number | 866.3236 [🔎] |
Decision | Granted (DENG) |
510(k) Premarket Notification | Device 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 Board | Microbiology |
Classification Advisory | Microbiology |
Type | Direct |
Date Received | 2019-06-24 |
Decision Date | 2020-05-11 |
Reclassification Order: | Reclassification Order |