FDA applicant

Polysciences, Inc.

Warrington, PA3 decisions1978–19920 recalls

FDA records 3 decisions for Polysciences, Inc. (Warrington, PA) from 1978 to 1992: 3 510(k) clearances. Most are in product codes JJH (Clinical Sample Concentrator) and LYF (Pneumocystis Carinii). 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 Polysciences, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Polysciences, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Polysciences, Inc.

Which product codes does it file in?

What has FDA decided for it lately?