FDA applicant

Gelman Instrument Co.

Mchenry, IL11 decisions1977–19780 recalls

FDA records 11 decisions for Gelman Instrument Co. (Mchenry, IL) from 1977 to 1978: 11 510(k) clearances. Most are in product codes DAY (Complement C5, Antigen, Antiserum, Control) and CJO (Alpha-Naphthyl Phosphate, Alkaline Phosphatase…). 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, immunology panel, where it files most

How often FDA has decided Gelman Instrument Co.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Gelman Instrument Co. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Gelman Instrument Co.’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 “Gelman”

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

Gelman Sciences, Inc. 32

Gelman Instrument Co.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Gelman”