FDA applicant

Smithkline Diagnostics, Inc.

Mchenry, IL42 decisions1976–19960 recalls

FDA records 42 decisions for Smithkline Diagnostics, Inc. (Mchenry, IL) from 1976 to 1996: 42 510(k) clearances. Most are in product codes IYO (System, Imaging, Pulsed Echo, Ultrasonic) and JHS (Differential Rate Kinetic Method, Cpk Or…). Its devices cite 1 predicate, 1 of them its own earlier devices. 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 Smithkline Diagnostics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Smithkline Diagnostics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Smithkline”

FDA records each applicant name separately; these may or may not be the same firm.

Smithkline Beecham Consumer Healthcare Products 1 Smithkline Beecham Corp. 1

Smithkline Diagnostics, 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?

Other applicant names beginning “Smithkline”