PLATELIA TOXO IGM KIT MODEL 26211— 510(k) K090847

Substantially Equivalent

Bio-Rad Laboratories

FDA 510(k) clearance K090847 for PLATELIA TOXO IGM KIT MODEL 26211, Substantially Equivalent on 2009-07-01. Applicant: Bio-Rad Laboratories.

Clearance details

Applicant: Bio-Rad Laboratories
Product code: Code LGD
Advisory panel: Microbiology
Date received: 2009-03-30
Decision date: 2009-07-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Redmond, WA, 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.