Janssen Diagnostics: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Janssen Diagnostics”, plus 1 PMA 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 |
|---|---|---|---|
| OCB | Rt-Pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastasis Detection | 1 | 0 |
Review panels
- Immunology (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P060017 | PMA | GENESEARCH BREAST LYMPH NODE(BLN) ASSAY | 2007-07-16 |
Recalls
openFDA lists no recalls under a recalling firm named Janssen Diagnostics.
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.
Device clinical trials
An industry sponsor named Janssen Diagnostics is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT00551278: Validation Study Using the GeneSearch BLN Assay to Test Sentinel Lymph Nodes From Patients With Breast Cancer (Completed, started 2007-10)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Janssen Biochimica (1 510(k)s)
- Janssen Pharmaceutica, Inc. (1 510(k)s)
- Janssen Pharmaceutica NV (1 510(k)s)
- Janssen Research Foundation (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Janssen Diagnostics?
FDA lists 0 510(k) clearances under the applicant name “Janssen Diagnostics”, plus 1 PMA 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 Janssen Diagnostics?
The most frequent FDA product codes under this applicant name are OCB (Rt-Pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastasis Detection, 1).
Next steps
- See all 0 Janssen Diagnostics clearances with predicates and recalls
- Run predicate analysis for product code OCB, Janssen Diagnostics'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.