GeneSTAT.MDx Coccidioides Assay
FDA 510(k) clearance DEN170041 · decided 2017-11-29
Clearance details
- K-number
- DEN170041
- Device name
- GeneSTAT.MDx Coccidioides Assay
- Applicant
- Dxna, LLC
- Decision
- Unknown
- Date received
- 2017-08-01
- Decision date
- 2017-11-29
- Days to decision
- 120 days
- Clearance type
- Direct
- Product code
- QAA
- Device class
- 2
- Regulation number
- 866.3376
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- St George, UT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.