FDA applicant

Shandon, Inc.

Pittsburgh, PA5 decisions1978–19890 recalls

FDA records 5 decisions for Shandon, Inc. (Pittsburgh, PA) from 1978 to 1989: 5 510(k) clearances. Most are in product codes HYB (Eosin Y) and KIO (Slide Stainer, Immersion Type). 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, hematology panel, where it files most

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

FDA decisions per year

No FDA decision for Shandon, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Shandon”

FDA records each applicant name separately; these may or may not be the same firm.

Shandon Diagnostics Limited 1

Shandon, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Shandon”