The following data is part of a premarket notification filed by Centers For Disease Control And Prevention with the FDA for Non-variola Orthopoxvirus Real-time Pcr Primer And Probe Set.
| Device ID | K181205 |
| 510k Number | K181205 |
| Device Name: | Non-variola Orthopoxvirus Real-time PCR Primer And Probe Set |
| Classification | Non-variola Orthopoxvirus Real-time Pcr Primer And Probe Set |
| Applicant | Centers For Disease Control And Prevention 1600 Clifton Road NE, MS-C18 Atlanta, GA 30329 |
| Contact | Yon Yu |
| Correspondent | Yon Yu Centers For Disease Control And Prevention 1600 Clifton Road NE, MS-C18 Atlanta, GA 30329 |
| Product Code | PBK |
| CFR Regulation Number | 866.3315 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-07 |
| Decision Date | 2018-09-20 |
| Summary: | summary |