510(k) DEN190025
- Device
- OraQuick Ebola Rapid Antigen Test
- Applicant
- OraSure Technologies, Inc.
- 510(k) number
- DEN190025
- Product code
- QID
- Decision
- Unknown (DENG)
- Decision date
- 2019-10-10
- Date received
- 2019-05-13
- Regulation
- 866.4002
- Classification name
- Device To Detect Antigens Of Biothreat Microbial Agents In Human Clinical Specimens
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Tiffany Miller
- Address
- 220 E. First St. Bethlehem PA US 18015 18015
FDA Registration Numbers#
- 3004142665
- 3003297763
- 3022474803
Source Documents#
510(k) summary PDF not indicated by FDA