Darmiyan, Inc.: FDA clearances and approvals
Darmiyan, Inc. 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 |
|---|---|---|---|
| QWT | Prognostic Assessment Software Of Mild Cognitive Impairment | 1 | 0 |
Review panels
- Neurology (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN220066 | De Novo | Prognostic Assessment Software Of Mild Cognitive Impairment | 2024-01-11 |
Recalls
openFDA lists no recalls under a recalling firm named Darmiyan, Inc..
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 Darmiyan, Inc. have?
Darmiyan, Inc. has 0 FDA 510(k) clearances, plus 1 De Novo decision, across 1 product code in 1 review panel.
What devices does Darmiyan, Inc. make?
Its most frequent FDA product codes are QWT (Prognostic Assessment Software Of Mild Cognitive Impairment, 1).
Has Darmiyan, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Darmiyan, Inc. Related entities may recall under other names.
Next steps
- See all 0 Darmiyan, Inc. clearances with predicates and recalls
- Run predicate analysis for product code QWT, Darmiyan, Inc.'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.