Stemcell Technologies Canada, Inc.: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Stemcell Technologies Canada, Inc.”, plus 1 De Novo decision, across 1 product code in 1 review panel. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QYO | Hematopoietic Cell Enrichment Kit | 1 | 0 |
Review panels
- Medical Genetics (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN220090 | De Novo | Hematopoietic Cell Enrichment Kit | 2023-11-06 |
Recalls
openFDA lists no recalls under a recalling firm named Stemcell Technologies Canada, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Stemcell Technologies Canada, Inc.?
FDA lists 0 510(k) clearances under the applicant name “Stemcell Technologies Canada, Inc.”, plus 1 De Novo decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
Which FDA product codes appear under Stemcell Technologies Canada, Inc.?
The most frequent FDA product codes under this applicant name are QYO (Hematopoietic Cell Enrichment Kit, 1).
Next steps
- See all 0 Stemcell Technologies Canada, Inc. clearances with predicates and recalls
- Run predicate analysis for product code QYO, Stemcell Technologies Canada, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.