510(k) Report

FDA applicant

Itc, Inc.

Edison, NJ1 decision2002–20021 recall

FDA records 1 decision for Itc, Inc. (Edison, NJ) in 2002: 1 510(k) clearance. All are in product code GFO (Activated Partial Thromboplastin). Its devices cite 1 predicate, 0 of them its own earlier devices. 1 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, hematology panel, where it files most

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

FDA decisions per year

No FDA decision for Itc, Inc. since 2007.

Recalls per year

1in 2013

2013: 1
2007high 1 (2013) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Itc, 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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Which product codes does it file in?

  • GFOActivated Partial Thromboplastin1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K014008Hemochron JR. Citrate Aptt CuvetteItc, Inc. · 20021 recall

The one decision as Itc, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K014008Hemochron Jr. Citrate APTT Cuvette 510(k) K014008 A unitized microcoagulation test…Dec 19, 2013Class II