510(k) DEN160016
- Device
- Variola virus Real-Time PCR Assay
- Applicant
- Centers For Disease Control and Prevention (CDC)
- 510(k) number
- DEN160016
- Product code
- PRA
- Decision
- Unknown (DENG)
- Decision date
- 2017-02-06
- Date received
- 2016-04-14
- Regulation
- 866.3316
- Classification name
- Variola Virus Nucleic Acid-Based Detection Assay
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- YON YU
- Address
- 1600 Clifton Rd. NE, Ms-C18 Atlanta GA US 30329 30329
FDA Registration Numbers#
- 1050190
Source Documents#
510(k) summary PDF not indicated by FDA