ARCHITECT STAT TROPONIN-I IMMUNOASSAY— 510(k) K041192

Substantially Equivalent

Fisher Diagnostics

FDA 510(k) clearance K041192 for ARCHITECT STAT TROPONIN-I IMMUNOASSAY, Substantially Equivalent on 2004-08-12. Applicant: Fisher Diagnostics.

Clearance details

Applicant: Fisher Diagnostics
Product code: Code MMI
Advisory panel: Clinical Chemistry
Date received: 2004-05-06
Decision date: 2004-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Middletown, VA, 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.