FDA applicant

Anatech, Ltd.

Battle Creek, MI14 decisions1984–19880 recalls

FDA records 14 decisions for Anatech, Ltd. (Battle Creek, MI) from 1984 to 1988: 14 510(k) clearances. Most are in product codes IFP (Formalin, Neutral Buffered) and KEM (Agent, Clearing). 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, pathology panel, where it files most

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

FDA decisions per year

No FDA decision for Anatech, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Anatech, Ltd.’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

Anatech, Ltd.

Which product codes does it file in?

What has FDA decided for it lately?