FDA applicant

Clinical Analysis Corporation, Inc.

Quakertown, PA1 decision2004–20040 recalls

FDA records 1 decision for Clinical Analysis Corporation, Inc. (Quakertown, PA) in 2004: 1 510(k) clearance. All are in product code CEM (Electrode, Ion Specific, Potassium). 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 Clinical Analysis Corporation, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Clinical Analysis Corporation, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Clinical Analysis Corporation, Inc.

Which product codes does it file in?

What has FDA decided for it lately?