Clearance Summary
AQT90 FLEX ANALYZER, AQT90 FLEX MYOGLOBIN TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LVLS 1-3, AQT90 FLEX MYO CAL CARTRIDGE.. received FDA 510(k) clearance under submission number K112161, sponsored by Radiometer Medical Aps. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2012-01-20.
- Submission: K112161
- Applicant / Sponsor: Radiometer Medical Aps
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2560
- Decision date: 2012-01-20
Classification & Regulation
This clearance is catalogued under FDA product code KHO and 21 CFR 862.2560, within the Clinical Chemistry review panel as a Class I device.