510(k) Report

FDA applicant

Advanced Biomedical Methods, Inc.

Niles, IL21 decisions1976–19940 recalls

FDA records 21 decisions for Advanced Biomedical Methods, Inc. (Niles, IL) from 1976 to 1994: 21 510(k) clearances. Most are in product codes CIC (Cresolphthalein Complexone, Calcium) and CGA (Glucose Oxidase, Glucose). 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 Advanced Biomedical Methods, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Advanced Biomedical Methods, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Advanced Biomedical Methods, 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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