510(k) DEN170041
- Device
- GeneSTAT.MDx Coccidioides Assay
- Applicant
- Dxna, LLC
- 510(k) number
- DEN170041
- Product code
- QAA
- Decision
- Unknown (DENG)
- Decision date
- 2017-11-29
- Date received
- 2017-08-01
- Regulation
- 866.3376
- Classification name
- Coccidioides Spp. Nucleic Acid Detection System For Respiratory Specimens
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Ernie Sumsion
- Address
- 180 N 300 E St George UT US 84770 84770
Source Documents#
510(k) summary PDF not indicated by FDA