FDA applicant

Serono Diagnostics, Inc.

Norwell, MA25 decisions1984–19960 recalls

FDA records 25 decisions for Serono Diagnostics, Inc. (Norwell, MA) from 1984 to 1996: 25 510(k) clearances. Most are in product codes CEP (Radioimmunoassay, Luteinizing Hormone) and JHI (Visual, Pregnancy Hcg, Prescription Use). Its devices cite 2 predicates, 0 of them its own earlier devices. 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 Diagnostics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Serono Diagnostics, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Serono”

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

Serono-Baker Diagnostics, Inc. 23 Serono Laboratories, Inc. 10 Serono, Inc. 1 Serono Baker Diagnostics System 1

Serono Diagnostics, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Serono”