FDA applicant

Chem-Elec, Inc.

Mchenry, IL9 decisions1981–19960 recalls

FDA records 9 decisions for Chem-Elec, Inc. (Mchenry, IL) from 1981 to 1996: 9 510(k) clearances. Most are in product codes CGA (Glucose Oxidase, Glucose) and JFS (Coulometric, Chloride). 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 Chem-Elec, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Chem-Elec, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Chem-Elec, 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

Other applicant names beginning “Chem-Elec”

FDA records each applicant name separately; these may or may not be the same firm.

Chem-Specialties Sdn Bhd 1 Chem-E-Dent 1 Chem Pharm, Inc. 1

Chem-Elec, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Chem-Elec”