510(k) K221658
K221658 is an FDA 510(k) premarket notification submitted by Centers for Disease Control and Prevention for the device "Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set". The FDA issued a decision of Substantially Equivalent on June 10, 2022. The device falls under product code PBK (Non-Variola Orthopoxvirus Real-Time Pcr Primer And Probe Set), a Class II device regulated under 21 CFR 866.3315. Centers for Disease Control and Prevention has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 10, 2022
- Date Received
- June 8, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Non-Variola Orthopoxvirus Real-Time Pcr Primer And Probe Set
- Device Class
- Class II
- Regulation Number
- 866.3315
- Review Panel
- MI
- Submission Type
In vitro qualitative detection of non-variola Orthopoxvirus nucleic acids extracted from human specimens or viral culture.