VANCOUVER BIOTECH HUMAN CARDIAC TROPONIN I IMMUNOASSAY TEST KIT— 510(k) K050644

Substantially Equivalent

Vancouver Biotech , Ltd.

FDA 510(k) clearance K050644 for VANCOUVER BIOTECH HUMAN CARDIAC TROPONIN I IMMUNOASSAY TEST KIT, Substantially Equivalent on 2005-08-17. Applicant: Vancouver Biotech , Ltd..

Clearance details

Applicant: Vancouver Biotech , Ltd.
Product code: Code MMI
Advisory panel: Clinical Chemistry
Date received: 2005-03-14
Decision date: 2005-08-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vancouver, CA

Download summary PDF View on FDA.gov ↗

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.