Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set
FDA 510(k) clearance K222558 · decided 2022-08-30
Clearance details
- K-number
- K222558
- Device name
- Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set
- Applicant
- Centers for Disease Control and Prevention
- Decision
- Substantially Equivalent
- Date received
- 2022-08-24
- Decision date
- 2022-08-30
- Days to decision
- 6 days
- Clearance type
- Special
- Product code
- PBK
- Device class
- 2
- Regulation number
- 866.3315
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Atlanta, GA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set (K221834) | Centers for Disease Control and Prevention | 2022-06-24 |
| Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set (K221658) | Centers for Disease Control and Prevention | 2022-06-10 |
| NON-VARIOLA ORTHOPOXVIRUS REAL-TIME PCR PRIMER AND PROBE SET (DEN070001) | Centers for Disease Control and Prevention | 2018-09-21 |
| Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set (K181205) | Centers for Disease Control and Prevention | 2018-09-20 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| AFP MID-PREGNANCY REFERENCE PREPARATION (P820077) | Centers for Disease Control and Prevention | 1984-11-30 |