TROPONIN-I TEST SYSTEM— 510(k) K964862

Substantially Equivalent

Dade Intl., Inc.

FDA 510(k) clearance K964862 for TROPONIN-I TEST SYSTEM, Substantially Equivalent on 1997-02-10. Applicant: Dade Intl., Inc..

Clearance details

Applicant: Dade Intl., Inc.
Product code: Code MMI
Advisory panel: Clinical Chemistry
Date received: 1996-12-04
Decision date: 1997-02-10
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.