K102441

Substantially Equivalent

NANO-CHECK AMI 2 IN 1 CARDIAC MARKER, CTNL AND MYOGLOBIN

Applicant: Nano-Ditech Corporation
Product code: MMI
Advisory panel: Clinical Chemistry
Date received: 2010-07-29
Decision date: 2010-10-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Cranbury, NJ, 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.