ACCESS ACCUTNI REAGENT, ACCESS ACCUTNI CALIBRATOR, UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM— 510(k) K121790

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K121790 for ACCESS ACCUTNI REAGENT, ACCESS ACCUTNI CALIBRATOR, UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, Substantially Equivalent on 2013-09-25. Applicant: Beckman Coulter, Inc..

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code MMI
Advisory panel: Clinical Chemistry
Date received: 2012-06-18
Decision date: 2013-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chaska, MN, US

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Adverse events under product code MMI

product code MMI

Injury: 172
Malfunction: 3,762
Total: 3,934

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.