510(k) Report

FDA applicant

Protos Laboratories

Mchenry, IL6 decisions1979–19800 recalls

FDA records 6 decisions for Protos Laboratories (Mchenry, IL) from 1979 to 1980: 6 510(k) clearances. Most are in product codes DCK (C-Reactive Protein, Antigen, Antiserum, And…) and DEM (Alpha-1-Antitrypsin, Antigen, Antiserum, Control). 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 Protos Laboratories’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Protos Laboratories since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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