MODIFICATION TO VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK/ CALIBRATORS— 510(k) K020662

Substantially Equivalent

Ortho-Clinical Diagnostics

FDA 510(k) clearance K020662 for MODIFICATION TO VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK/ CALIBRATORS, Substantially Equivalent on 2002-04-12. Applicant: Ortho-Clinical Diagnostics.

Clearance details

Applicant: Ortho-Clinical Diagnostics
Product code: Code MMI
Advisory panel: Clinical Chemistry
Date received: 2002-03-01
Decision date: 2002-04-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, US

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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.