UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100— 510(k) K023764

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K023764 for UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100, Substantially Equivalent on 2003-01-28. Applicant: Beckman Coulter, Inc..

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code JJE
Advisory panel: Clinical Chemistry
Date received: 2002-11-12
Decision date: 2003-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chaska, MN, US

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Adverse events under product code JJE

product code JJE

Death: 6
Injury: 441
Malfunction: 25,011
Other: 1
Total: 25,459

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.