510(k) Report

FDA applicant

Antibodies, Inc.

Mchenry, IL16 decisions1977–19890 recalls

FDA records 16 decisions for Antibodies, Inc. (Mchenry, IL) from 1977 to 1989: 16 510(k) clearances. Most are in product codes CFN (Method, Nephelometric, Immunoglobulins (G, A, M)) and KLQ (Radioimmunoassay, Amikacin). 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 toxicology panel, where it files most

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

FDA decisions per year

No FDA decision for Antibodies, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Antibodies, 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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