FDA applicant

Haemoscope Corp.

Skokie, IL7 decisions1989–20077 recalls

FDA records 7 decisions for Haemoscope Corp. (Skokie, IL) from 1989 to 2007: 7 510(k) clearances. Most are in product codes GKP (Instrument, Coagulation, Automated) and JPA (System, Multipurpose For In Vitro Coagulation…). Its devices cite 1 predicate, 0 of them its own earlier devices. 7 recalls are 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 Haemoscope Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2007

2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

2in 2022

2007high 2 (2011) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Haemoscope Corp.’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

Haemoscope Corp.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?