FDA applicant

Genzyme Diagnostics

San Carlos, CA5 decisions1996–20052 recalls

FDA records 5 decisions for Genzyme Diagnostics (San Carlos, CA) from 1996 to 2005: 5 510(k) clearances. Most are in product codes JHI (Visual, Pregnancy Hcg, Prescription Use) and MHI (Giardia Spp.). Its devices cite 2 predicates, 0 of them its own earlier devices. 2 recalls are 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 Genzyme Diagnostics’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Genzyme Diagnostics since 2007.

Recalls per year

1in 2025

2007high 1 (2025) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Genzyme Diagnostics’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 “Genzyme”

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

Genzyme Corp. 35 Genzyme Surgical Product (Genzyme Biosurgery) 9 Genzyme Biosurgery 5 Genzyme Diagnostics P.E.I., Inc. 2

Genzyme Diagnostics

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?

What has been recalled?

Other applicant names beginning “Genzyme”