AQT90 FLEX ANALYZER, AQT90 FLEX MYOGLOBIN TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LVLS 1-3, AQT90 FLEX MYO CAL CARTRIDGE..— 510(k) K112161

Name: FDA 510(k) clearance K112161
Creator: U.S. Food and Drug Administration
Published: 2012-01-20

Substantially Equivalent

Radiometer Medical Aps

FDA 510(k) clearance K112161 for AQT90 FLEX ANALYZER, AQT90 FLEX MYOGLOBIN TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LVLS 1-3, AQT90 FLEX MYO CAL CARTRIDGE.., Substantially Equivalent on 2012-01-20. Applicant: Radiometer Medical Aps. Device class: 1.

Clearance details

Applicant: Radiometer Medical Aps
Product code: Code KHO
Device class: Class 1
Regulation: 21 CFR 862.2560
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 ↗

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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.