FDA applicant

Pb Diagnostics, Inc.

Westwood, MA4 decisions1991–19930 recalls

FDA records 4 decisions for Pb Diagnostics, Inc. (Westwood, MA) from 1991 to 1993: 4 510(k) clearances. Most are in product codes MJX (Kit, Serological, Positive Control) and LKQ (Antibody Igm,If, Cytomegalovirus Virus). 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, microbiology panel, where it files most

How often FDA has decided Pb Diagnostics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

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

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Pb Diagnostics, Inc.

Which product codes does it file in?

What has FDA decided for it lately?