Variola virus Real-Time PCR Assay
FDA 510(k) clearance DEN160016 · decided 2017-02-06
Clearance details
- K-number
- DEN160016
- Device name
- Variola virus Real-Time PCR Assay
- Applicant
- Centers For Disease Control and Prevention (CDC)
- Decision
- Unknown
- Date received
- 2016-04-14
- Decision date
- 2017-02-06
- Days to decision
- 298 days
- Clearance type
- Direct
- Product code
- PRA
- Device class
- 2
- Regulation number
- 866.3316
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Atlanta, GA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.