K181205 is an FDA 510(k) clearance for the Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set. This device is classified as a Non-variola Orthopoxvirus Real-time Pcr Primer And Probe Set (Class II — Special Controls, product code PBK).
Submitted by Centers For Disease Control and Prevention (Atlanta, US). The FDA issued a Cleared decision on September 20, 2018, 136 days after receiving the submission on May 7, 2018.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3315. In Vitro Qualitative Detection Of Non-variola Orthopoxvirus Nucleic Acids Extracted From Human Specimens Or Viral Culture..
| 510(k) Number | K181205 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 07, 2018 |
| Decision Date | September 20, 2018 |
| Days to Decision | 136 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | PBK — Non-variola Orthopoxvirus Real-time Pcr Primer And Probe Set |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.3315 |
| Definition | In Vitro Qualitative Detection Of Non-variola Orthopoxvirus Nucleic Acids Extracted From Human Specimens Or Viral Culture. |