RAMP TROPONIN I ASSAY— 510(k) K033745

Name: FDA 510(k) clearance K033745
Creator: U.S. Food and Drug Administration
Published: 2004-05-17

Substantially Equivalent

Response Biomedical Corp.

FDA 510(k) clearance K033745 for RAMP TROPONIN I ASSAY, Substantially Equivalent on 2004-05-17. Applicant: Response Biomedical Corp.. Device class: 2.

Clearance details

Applicant: Response Biomedical Corp.
Product code: Code MMI
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 2003-12-01
Decision date: 2004-05-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Burnaby, British Columbia, CA

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.