K062838

Substantially Equivalent

VITROS TROPONIN I ES ASSAY, INCLUDING REAGENT PACK, CALIBRATORS AND RANGE VERIFIERS, MODELS 680 2301, 2302 AND 2303

Applicant: Ortho-Clinical Diagnostics
Product code: MMI
Advisory panel: Clinical Chemistry
Date received: 2006-09-21
Decision date: 2006-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, US

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.