510(k) DEN070001
- Device
- NON-VARIOLA ORTHOPOXVIRUS REAL-TIME PCR PRIMER AND PROBE SET
- Applicant
- Centers for Disease Control and Prevention
- 510(k) number
- DEN070001
- Product code
- PBK
- Decision
- Unknown (DENG)
- Decision date
- 2018-09-21
- Date received
- 2007-01-16
- Regulation
- 866.3315
- Classification name
- Non-Variola Orthopoxvirus Real-Time Pcr Primer And Probe Set
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Post-NSE
- Third party reviewed
- N
Applicant Contact#
- Contact
- HYE-JOO KIM
- Address
- 1600 Clifton Rd., NE Atlanta GA US 30333 30333
FDA Registration Numbers#
- 1050190
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code PBK#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K222558 | Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set | Centers for Disease Control and Prevention | 2022-08-30 |
| K221834 | Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set | Centers for Disease Control and Prevention | 2022-06-24 |
| K221658 | Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set | Centers for Disease Control and Prevention | 2022-06-10 |
| K181205 | Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set | Centers for Disease Control and Prevention | 2018-09-20 |