K112161

Substantially Equivalent

AQT90 FLEX ANALYZER, AQT90 FLEX MYOGLOBIN TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LVLS 1-3, AQT90 FLEX MYO CAL CARTRIDGE..

Applicant: Radiometer Medical Aps
Product code: KHO
Advisory panel: Clinical Chemistry
Date received: 2011-07-27
Decision date: 2012-01-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Broenshoej, DK

Download summary PDF View on FDA.gov ↗

Adverse events under product code KHO

product code KHO

Malfunction: 1,339
Total: 1,339

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.