510(k) Report

FDA applicant

J & S Medical Assoc., Inc.

Framingham, MA2 decisions1993–20020 recalls

FDA records 2 decisions for J & S Medical Assoc., Inc. (Framingham, MA) from 1993 to 2002: 2 510(k) clearances. Most are in product codes JJW (Urinalysis Controls (Assayed And Unassayed)) and DHR (System, Test, Rheumatoid Factor). 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 J & S Medical Assoc., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for J & S Medical Assoc., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • JJWUrinalysis Controls (Assayed And Unassayed)1decision
  • DHRSystem, Test, Rheumatoid Factor1decision

What has FDA decided for it lately?

  • K022085J&S Medical Sentry Urine Dipstick ControlJ & S Medical Assoc., Inc. · 2002
  • K932437Eye Spot RF TestJ & S Medical Assoc., Inc. · 1993

All 2 as J & S Medical Assoc., Inc. →