Cytocell, Ltd.: FDA clearances and approvals
Cytocell, Ltd. has 0 FDA 510(k) clearances, plus 1 De Novo decision, across 1 product code in 1 review panel. openFDA lists 14 product recalls by a recalling firm named Cytocell, Ltd.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QDI | Fish Based Detection Of Chromosomal Abnormalities From Patients With Hematologic Malignancies | 1 | 0 |
Review panels
- Pathology (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN170070 | De Novo | Fish Based Detection Of Chromosomal Abnormalities From Patients With Hematologic Malignancies | 2018-12-21 |
Recalls
14 product recalls in 13 recall events; 7 initiated in the last five years. Most recent: 2023-05-24.
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 Cytocell, Ltd. have?
Cytocell, Ltd. has 0 FDA 510(k) clearances, plus 1 De Novo decision, across 1 product code in 1 review panel.
What devices does Cytocell, Ltd. make?
Its most frequent FDA product codes are QDI (Fish Based Detection Of Chromosomal Abnormalities From Patients With Hematologic Malignancies, 1).
Has Cytocell, Ltd. had device recalls?
openFDA lists 14 product recalls in 13 recall events by a recalling firm whose name matches Cytocell, Ltd; the most recent began 2023-05-24. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 0 Cytocell, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code QDI, Cytocell, Ltd.'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.