FDA applicant

Dimension Diagnostics

St. Charles, MO8 decisions1985–19870 recalls

FDA records 8 decisions for Dimension Diagnostics (St. Charles, MO) from 1985 to 1987: 8 510(k) clearances. Most are in product codes JJY (Multi-Analyte Controls, All Kinds (Assayed)) and JIX (Calibrator, Multi-Analyte Mixture). 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 Dimension Diagnostics’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Dimension Diagnostics since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Dimension”

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

Dimension Inx Corp. 1 Dimension Specialty Co., Inc. 1

Dimension Diagnostics

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Dimension”