FDA applicant

Clinical Data, Inc.

Boston, MA37 decisions1982–20070 recalls

FDA records 37 decisions for Clinical Data, Inc. (Boston, MA) from 1982 to 2007: 37 510(k) clearances. Most are in product codes KNK (Acid, Uric, Uricase (Colorimetric)) and DRX (Electrode, Electrocardiograph). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Clinical Data”.

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 Data, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2007

2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Clinical Data, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?