FDA applicant

Beckman-Diagnostic Systems Group

Brea, CA11 decisions1993–19941 recall

FDA records 11 decisions for Beckman-Diagnostic Systems Group (Brea, CA) from 1993 to 1994: 11 510(k) clearances. Most are in product codes LCM (Enzyme Immunoassay, Phencyclidine) and DFT (Igm, Antigen, Antiserum, Control). 1 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 Beckman-Diagnostic Systems Group’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Beckman-Diagnostic Systems Group since 2007.

Recalls per year

1in 2019

2007high 1 (2019) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Beckman-Diagnostic Systems Group by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Beckman-Diagnostic”

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

Beckman Coulter, Inc. 286 Beckman Instruments, Inc. 281 Beckman Coulter Ireland, Inc. 7 Beckman 6 Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. 2 Beckman Analytical and Biotechnology Development 1 Beckman Coulter Cellular 1 Beckman Coulter Biomedical GmbH 1

Beckman-Diagnostic Systems Group

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?

What has been recalled?

Other applicant names beginning “Beckman-Diagnostic”