FDA applicant

Seragen Diagnostics, Inc.

Mchenry, IL20 decisions1982–19870 recalls

FDA records 20 decisions for Seragen Diagnostics, Inc. (Mchenry, IL) from 1982 to 1987: 20 510(k) clearances. Most are in product codes JJT (Enzyme Controls (Assayed And Unassayed)) and GKL (Counter, Cell, Automated (Particle Counter)). 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 Seragen Diagnostics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

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

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Seragen Diagnostics, Inc.

Which product codes does it file in?

What has FDA decided for it lately?