510(k) Report

FDA applicant

J.S. Medical Assoc.

Natick, MA18 decisions1983–19930 recalls

FDA records 18 decisions for J.S. Medical Assoc. (Natick, MA) from 1983 to 1993: 18 510(k) clearances. Most are in product codes KTN (System, Test, Infectious Mononucleosis) and JMO (Ferrozine (Colorimetric) Iron Binding Capacity). 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 J.S. Medical Assoc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for J.S. Medical Assoc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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