FDA applicant

Medical Specialties Intl., Inc.

South Plainfield, NJ5 decisions1989–19970 recalls

FDA records 5 decisions for Medical Specialties Intl., Inc. (South Plainfield, NJ) from 1989 to 1997: 5 510(k) clearances. Most are in product codes JJY (Multi-Analyte Controls, All Kinds (Assayed)) and JCN (Control, Cell Counter, Normal And Abnormal). 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 Intl., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Medical Specialties Intl., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Medical Specialties Intl., Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?