510(k) DEN190031
- Device
- NP Screen
- Applicant
- Advance Sentry Corporation
- 510(k) number
- DEN190031
- Product code
- OJY
- Decision
- Unknown (DENG)
- Decision date
- 2020-05-11
- Date received
- 2019-06-24
- Regulation
- 866.3236
- Classification name
- Device To Detect Or Measure Nucleic Acid From Viruses Associated With Head And Neck Cancers
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Leo Chui
- Address
- 7155 Woodbine Ave., Suite 202 Markham CA L3R 1A3 L3R 1A3
Source Documents#
510(k) summary PDF not indicated by FDA