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. Device class: 2.
Clearance details
- Applicant
- Radiometer Medical Aps
- Product code
- Code JHX
- Device class
- Class 2
- Regulation
- 21 CFR 862.1215
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dk-Bronshoj, DK
Recent devices under product code JHX
view all- K234005 — Access CK-MB
- K212648 — VITROS Immunodiagnostic Products CK-MB Reagent Pack
- K120326 — AQT90 FLEX CKMB TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LEVELS 1-3, AQT90 FLEX CKMB CAL CARTRIDGE
- K081360 — PATHFAST CK-MB-II, PATHFAST MYO-II
- K051650 — STRATUS CS ACUTE CARE MB ISOENZYME OF CREATINE KINASE (CKMB) TEST PAK; STRATUS CS ACUTE CARE CKMB TESTPAK.
More clearances from Radiometer Medical Aps
view allData sourced from openFDA. This site is unofficial and independent of the FDA.