Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set
FDA 510(k) clearance K221658 · decided 2022-06-10
Clearance details
- K-number
- K221658
- Device name
- Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set
- Applicant
- Centers for Disease Control and Prevention
- Decision
- Substantially Equivalent
- Date received
- 2022-06-08
- Decision date
- 2022-06-10
- Days to decision
- 2 days
- Clearance type
- Traditional
- 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
+ Add to Predicate Builder ◉ Watch Centers for Disease Control and Prevention
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 (K222558) | Centers for Disease Control and Prevention | 2022-08-30 |
| 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 (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 |