510(k) Report

FDA applicant

Medical Specialties Laboratories

Mchenry, IL5 decisions1981–19850 recalls

FDA records 5 decisions for Medical Specialties Laboratories (Mchenry, IL) from 1981 to 1985: 5 510(k) clearances. Most are in product codes KIS (Sera, Animal And Human) and JPK (Mixture, Hematology Quality 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, hematology panel, where it files most

How often FDA has decided Medical Specialties Laboratories’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Medical Specialties Laboratories since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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