510(k) Report

FDA applicant

Beckman

Brea, CA6 decisions1989–19991 recall

FDA records 6 decisions for Beckman (Brea, CA) from 1989 to 1999: 6 510(k) clearances. Most are in product codes JJE (Analyzer, Chemistry (Photometric, Discrete)…) and JJX (Single (Specified) Analyte Controls (Assayed…). Its devices cite 1 predicate, 0 of them its own earlier devices. 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’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Beckman since 2007.

Recalls per year

1in 2010

2010: 1
2007high 1 (2010) · low 0 (2007)2026

Class I Class II/III not classified

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

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Which product codes does it file in?

  • JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use2decisions
  • JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)1decision
  • DIHColorimetry, Cholinesterase1decision
  • DHXSystem, Test, Carcinoembryonic Antigen1decision
  • DIFDrug Mixture Control Materials1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K904219Synchron CX 7 Clinical AnalyzerBeckman · 19903cite it
  • K991707Modification to Access Cea Reagents for Use on the Access Immunoassay Analyzer, Models 33200, 33205, 33209…Beckman · 19992cite it
  • K904220Synchron CX4-CEBeckman · 19901cites it

What has FDA decided for it lately?

  • K991707Modification to Access Cea Reagents for Use on the Access Immunoassay Analyzer, Models 33200, 33205, 33209…Beckman · 1999
  • K971534Synchron Syustems Dat Drug Free Urine ControlBeckman · 1997
  • K935362P-Amylase ControlBeckman · 1994
  • K904219Synchron CX 7 Clinical AnalyzerBeckman · 1990
  • K904220Synchron CX4-CEBeckman · 19901 recall
  • K893583Beckman Cholinesterase Reagent KitBeckman · 1989

All 6 as Beckman →

What has been recalled?

1 recall linked to its devices; the latest:

  • K904220SYNCHRON CX4 CE Clinical System Part #: 756600 Product Usage: The Beckman SYNCHRON CX4…Aug 23, 2010

Other applicant names beginning “Beckman”

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

Beckman Coulter, Inc. 286Beckman Instruments, Inc. 281Beckman-Diagnostic Systems Group 11Beckman Coulter Ireland, Inc. 7Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. 2Beckman Analytical and Biotechnology Development 1Beckman Coulter Cellular 1Beckman Coulter Biomedical GmbH 1