K973616

Substantially Equivalent

TROPONIN I ASSAY FOR THE BAYER IMMUNO 1 SYSTEM

Applicant: Bayer Corp.
Product code: MMI
Advisory panel: Clinical Chemistry
Date received: 1997-09-23
Decision date: 1997-12-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, 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.