FDA applicant

Reference Diagnostics, Inc.

Bedford, MA17 decisions1990–20060 recalls

FDA records 17 decisions for Reference Diagnostics, Inc. (Bedford, MA) from 1990 to 2006: 17 510(k) clearances. Most are in product codes JIT (Calibrator, Secondary) and MRR (System, Test, Low Density, Lipoprotein). 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 Reference Diagnostics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

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

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Reference 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?