THE CARDIAC READER SYSTEM— 510(k) K000784

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K000784 for THE CARDIAC READER SYSTEM, Substantially Equivalent on 2000-05-18. Applicant: Roche Diagnostics Corp..

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code MMI
Advisory panel: Clinical Chemistry
Date received: 2000-03-10
Decision date: 2000-05-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Great Neck,, 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.