510(k) Report

FDA applicant

Artel, Inc.

Windham, ME4 decisions1987–19940 recalls

FDA records 4 decisions for Artel, Inc. (Windham, ME) from 1987 to 1994: 4 510(k) clearances. Most are in product codes JJQ (Colorimeter, Photometer, Spectrophotometer For…) and GIG (Hemoglobinometer). 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 Artel, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Artel, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Artel, 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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