FDA applicant

Clinical Controls Division

Hawaiian Gardens, CA1 decision2001–20010 recalls

FDA records 1 decision for Clinical Controls Division (Hawaiian Gardens, CA) in 2001: 1 510(k) clearance. All are in product code JJY (Multi-Analyte Controls, All Kinds (Assayed)). 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 Controls Division’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Clinical Controls Division since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Clinical Controls Division

Which product codes does it file in?

What has FDA decided for it lately?