510(k) Report

FDA applicant

Immunoprobe, Inc.

Washington, D.C., DC14 decisions1994–19970 recalls

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, last Nov 3, 2026

FIG. A — Illustration, immunology panel, where it files most

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.

FIG. 1 — Immunoprobe, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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.

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