AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX— 510(k) K163462
Substantially EquivalentRadiometer Medical Aps
FDA 510(k) clearance K163462 for AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX, Substantially Equivalent on 2017-09-21. Applicant: Radiometer Medical Aps.
Clearance details
- Applicant
- Radiometer Medical Aps
- Product code
- Code JHX
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dk-Bronshoj, DK
Data sourced from openFDA. This site is unofficial and independent of the FDA.