I-STAT CARDIAC TROPONIN (CTNI) TEST— 510(k) K031739

Substantially Equivalent

I-Stat Corporation

FDA 510(k) clearance K031739 for I-STAT CARDIAC TROPONIN (CTNI) TEST, Substantially Equivalent on 2003-09-02. Applicant: I-Stat Corporation.

Clearance details

Applicant: I-Stat Corporation
Product code: Code MMI
Advisory panel: Clinical Chemistry
Date received: 2003-06-04
Decision date: 2003-09-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: East Windsor, NJ, 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.