GeneSTAT.MDx Coccidioides Assay— 510(k) DEN170041
UnknownDxna, LLC
FDA 510(k) clearance DEN170041 for GeneSTAT.MDx Coccidioides Assay, Unknown on 2017-11-29. Applicant: Dxna, LLC. Device class: 2.
Clearance details
- Applicant
- Dxna, LLC
- Product code
- Code QAA
- Device class
- Class 2
- Regulation
- 21 CFR 866.3376
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Direct
- Location
- St George, UT, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.