Memorial Sloan-Kettering Cancer Center: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Memorial Sloan-Kettering Cancer Center”, 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 |
|---|---|---|---|
| PZM | Next Generation Sequencing Based Tumor Profiling Test | 1 | 0 |
Review panels
- Pathology (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN170058 | De Novo | Next Generation Sequencing Based Tumor Profiling Test | 2017-11-15 |
Recalls
openFDA lists no recalls under a recalling firm named Memorial Sloan-Kettering Cancer Center.
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 Memorial Sloan-Kettering Cancer Center?
FDA lists 0 510(k) clearances under the applicant name “Memorial Sloan-Kettering Cancer Center”, 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 Memorial Sloan-Kettering Cancer Center?
The most frequent FDA product codes under this applicant name are PZM (Next Generation Sequencing Based Tumor Profiling Test, 1).
Next steps
- See all 0 Memorial Sloan-Kettering Cancer Center clearances with predicates and recalls
- Run predicate analysis for product code PZM, Memorial Sloan-Kettering Cancer Center'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.