FDA applicant

Immuno Concepts, N.A., Ltd.

Sacramento, CA4 decisions2003–20230 recalls

FDA records 4 decisions for Immuno Concepts, N.A., Ltd. (Sacramento, CA) from 2003 to 2023: 4 510(k) clearances. Most are in product codes LKJ (Antinuclear Antibody, Antigen, Control) and DHN (Antinuclear Antibody, Indirect…). 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, immunology panel, where it files most

How often FDA has decided Immuno Concepts, N.A., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2007high 1 (2016) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Immuno Concepts, N.A., Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Other applicant names beginning “Immuno”

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

Immuno Concepts, Inc. 36 Immuno Nuclear Corp. 30 Immuno-Mycologics, Inc. 26 Immuno-Products Industries 12 Immuno Assay Corp. 10 Immuno-Diagnostic Products, Inc. 8 Immuno Diagnostic Center, Inc. 3 Immuno-Diagnostic Laboratories 2 Immuno-U.S., Inc. 1 Immuno Pathology Labs 1

Immuno Concepts, N.A., Ltd.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Immuno”