FDA applicant

Cirrus Diagnostics, Inc.

Chester, NJ10 decisions1991–19920 recalls

FDA records 10 decisions for Cirrus Diagnostics, Inc. (Chester, NJ) from 1991 to 1992: 10 510(k) clearances. Most are in product codes CGJ (Radioimmunoassay, Follicle-Stimulating Hormone) and DHA (System, Test, Human Chorionic Gonadotropin). 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 Cirrus Diagnostics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Cirrus 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 “Cirrus”

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

Cirrus Medical,Inc. 1

Cirrus Diagnostics, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Cirrus”