FDA applicant

Pb Diagnostic Systems, Inc.

Westwood, MA35 decisions1988–19940 recalls

FDA records 35 decisions for Pb Diagnostic Systems, Inc. (Westwood, MA) from 1988 to 1994: 35 510(k) clearances. Most are in product codes JHI (Visual, Pregnancy Hcg, Prescription Use) and KHO (Fluorometer, For Clinical Use). 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 Pb Diagnostic Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Pb Diagnostic Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Pb Diagnostic Systems, 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?