VBL SERUM TROPONIN I TEST, MODEL 1001— 510(k) K023505

Name: FDA 510(k) clearance K023505
Creator: U.S. Food and Drug Administration
Published: 2003-03-31

Substantially Equivalent

Vancouver Biotech , Ltd.

FDA 510(k) clearance K023505 for VBL SERUM TROPONIN I TEST, MODEL 1001, Substantially Equivalent on 2003-03-31. Applicant: Vancouver Biotech , Ltd.. Device class: 2.

Clearance details

Applicant: Vancouver Biotech , Ltd.
Product code: Code MMI
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 2002-10-18
Decision date: 2003-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Northridge, CA, US

Download summary PDF View on FDA.gov ↗

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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.