ACCESS IMMUNOASSAY SYSTEM TOXO IGM II ASSAY— 510(k) K031506

Name: FDA 510(k) clearance K031506
Creator: U.S. Food and Drug Administration
Published: 2003-06-02

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K031506 for ACCESS IMMUNOASSAY SYSTEM TOXO IGM II ASSAY, Substantially Equivalent on 2003-06-02. Applicant: Beckman Coulter, Inc.. Device class: 2.

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code LGD
Device class: Class 2
Regulation: 21 CFR 866.3780
Advisory panel: Microbiology
Date received: 2003-05-14
Decision date: 2003-06-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Chaska, MN, US

Download summary PDF View on FDA.gov ↗

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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.