FDA applicant

Immunostics Inc.,

Ocean, NJ25 decisions1984–20230 recalls

FDA records 25 decisions for Immunostics Inc., (Ocean, NJ) from 1984 to 2023: 25 510(k) clearances. Most are in product codes KHE (Reagent, Occult Blood) and JHJ (Agglutination Method, Human Chorionic…). Its devices cite 6 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Immunostics Co., Inc.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

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

How often FDA has decided Immunostics Inc.,’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2007high 4 (2017) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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See the 510(k) Report

Immunostics Inc.,

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?