510(k) K181205
- Device
- Non-variola Orthopoxvirus Real-time PCR Primer And Probe Set
- Applicant
- Centers For Disease Control And Prevention
- 510(k) number
- K181205
- Product code
- PBK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-09-20
- Date received
- 2018-05-07
- 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
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Yon Yu
- Address
- 1600 Clifton Rd. NE, Ms-C18 Atlanta GA US 30329 30329
FDA Registration Numbers#
- 1050190
Source Documents#
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 |
| DEN070001 | NON-VARIOLA ORTHOPOXVIRUS REAL-TIME PCR PRIMER AND PROBE SET | Centers for Disease Control and Prevention | 2018-09-21 |
Legacy Summary#
summary
FDA Review#
Decision Summary