STRATUS CARDIAC TROPONIN-I FLUOROMETRIC ENZYME IMMUNMNOASSAY & STRATUS CARDIAC TROPONIN-I CALIBRATORS— 510(k) K951890

Substantially Equivalent

Dade Intl., Inc.

FDA 510(k) clearance K951890 for STRATUS CARDIAC TROPONIN-I FLUOROMETRIC ENZYME IMMUNMNOASSAY & STRATUS CARDIAC TROPONIN-I CALIBRATORS, Substantially Equivalent on 1995-07-13. Applicant: Dade Intl., Inc..

Clearance details

Applicant: Dade Intl., Inc.
Product code: Code MMI
Advisory panel: Clinical Chemistry
Date received: 1995-04-24
Decision date: 1995-07-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, 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.