K033487

Substantially Equivalent

STRATUS CS ACUTE CARE TROPONIN I TESTPAK, MODEL CCTNI

Applicant: Dade Behring, Inc.
Product code: MMI
Advisory panel: Clinical Chemistry
Date received: 2003-11-04
Decision date: 2003-12-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newark,, DE, US

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.