FDA applicant

Serono-Baker Diagnostics, Inc.

Allentown, PA23 decisions1988–19920 recalls

FDA records 23 decisions for Serono-Baker Diagnostics, Inc. (Allentown, PA) from 1988 to 1992: 23 510(k) clearances. Most are in product codes CHP (Radioimmunoassay, Estradiol) and CDZ (Radioimmunoassay, Testosterones And…). 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 Serono-Baker Diagnostics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Serono-Baker Diagnostics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Serono-Baker Diagnostics, 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 “Serono-Baker”

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

Serono Diagnostics, Inc. 25 Serono Laboratories, Inc. 10 Serono, Inc. 1 Serono Baker Diagnostics System 1

Serono-Baker Diagnostics, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Serono-Baker”