FDA applicant

Qualisys Diagnostics, Inc.

Carlsbad, CA2 decisions1999–20002 recalls

FDA records 2 decisions for Qualisys Diagnostics, Inc. (Carlsbad, CA) from 1999 to 2000: 2 510(k) clearances. All are in product code LTJ (Prostate-Specific Antigen (Psa) For Management…). Its devices cite 3 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, immunology panel, where it files most

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

FDA decisions per year

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

Recalls per year

1in 2013

2007high 1 (2008) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Qualisys 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 “Qualisys”

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

Qualisys AB 1

Qualisys Diagnostics, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Qualisys”