Access Toxo IgM II— 510(k) K242095

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K242095 for Access Toxo IgM II, Substantially Equivalent on 2024-10-11. Applicant: Beckman Coulter, Inc..

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code LGD
Advisory panel: Microbiology
Date received: 2024-07-17
Decision date: 2024-10-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chaska, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LGD

product code LGD

Malfunction: 502
Total: 502

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.