K050975

Substantially Equivalent

NANO-CHECK AMI 3 IN 1 CARDIAC DISEASE TEST FOR CARDIAC TROPONIN I, CREATINE KINASE MB AND MYOGLOBIN

Applicant: Nano-Ditech Co.
Product code: MMI
Advisory panel: Clinical Chemistry
Date received: 2005-04-18
Decision date: 2006-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Great Neck, NY, 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.