FDA applicant
Oncogene Science, Inc.
FDA records 3 decisions for Oncogene Science, Inc. (Cambridge, MA) in 2000: 3 510(k) clearances. Most are in product codes LTJ (Prostate-Specific Antigen (Psa) For Management…) and NCW (System, Test, Her-2/Neu, Monitoring). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Oncogene Science, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Oncogene Science, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Oncogene Science, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report