Dxna, LLC: FDA clearances and approvals
Dxna, LLC has 0 FDA 510(k) clearances, plus 1 De Novo decision, across 1 product code in 1 review panel.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QAA | Coccidioides Spp. Nucleic Acid Detection System For Respiratory Specimens | 1 | 0 |
Review panels
- Microbiology (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN170041 | De Novo | Coccidioides Spp. Nucleic Acid Detection System For Respiratory Specimens | 2017-11-29 |
Recalls
openFDA lists no recalls under a recalling firm named Dxna, LLC.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Dxna, LLC have?
Dxna, LLC has 0 FDA 510(k) clearances, plus 1 De Novo decision, across 1 product code in 1 review panel.
What devices does Dxna, LLC make?
Its most frequent FDA product codes are QAA (Coccidioides Spp. Nucleic Acid Detection System For Respiratory Specimens, 1).
Has Dxna, LLC had device recalls?
openFDA lists no recalls under a recalling firm name matching Dxna, LLC. Related entities may recall under other names.
Next steps
- See all 0 Dxna, LLC clearances with predicates and recalls
- Run predicate analysis for product code QAA, Dxna, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.