Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl— 510(k) K162678

Substantially Equivalent

Roche Diagnostics

FDA 510(k) clearance K162678 for Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl, Substantially Equivalent on 2017-06-23. Applicant: Roche Diagnostics.

Clearance details

Applicant: Roche Diagnostics
Product code: Code LGD
Advisory panel: Microbiology
Date received: 2016-09-26
Decision date: 2017-06-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, 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.