FDA applicant

Haemachem, Inc.

St. Louis, MO4 decisions1984–19910 recalls

FDA records 4 decisions for Haemachem, Inc. (St. Louis, MO) from 1984 to 1991: 4 510(k) clearances. Most are in product codes GIS (Test, Fibrinogen) and KFF (Assay, Heparin). 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, hematology panel, where it files most

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

FDA decisions per year

No FDA decision for Haemachem, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Haemachem, 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

Haemachem, Inc.

Which product codes does it file in?

What has FDA decided for it lately?