K221658 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 June 10, 2022, 2 days after receiving the submission on June 8, 2022.
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 | K221658 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 08, 2022 |
| Decision Date | June 10, 2022 |
| Days to Decision | 2 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. |