FDA applicant

Catachem, Inc.

Port Chester, NY41 decisions1985–20070 recalls

FDA records 41 decisions for Catachem, Inc. (Port Chester, NY) from 1985 to 2007: 41 510(k) clearances. Most are in product codes CIG (Diazo Colorimetry, Bilirubin) and KNK (Acid, Uric, Uricase (Colorimetric)). 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, clinical chemistry panel, where it files most

How often FDA has decided Catachem, Inc.’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

No recall linked to its devices since 2007.

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

Planning a device like Catachem, 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

Catachem, Inc.

Which product codes does it file in?

What has FDA decided for it lately?