FDA applicant
Immunoprobe, Inc.
FDA records 14 decisions for Immunoprobe, Inc. (Washington, D.C., DC) from 1994 to 1997: 14 510(k) clearances. Most are in product codes MID (System, Test, Anticardiolipin Immunological) and JNL (Immunochemical, Thyroglobulin Autoantibody). 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 Immunoprobe, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Immunoprobe, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Immunoprobe, 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