AQT90 FLEX CKMB TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LEVELS 1-3, AQT90 FLEX CKMB CAL CARTRIDGE— 510(k) K120326
Substantially EquivalentRadiometer Medical Aps
FDA 510(k) clearance K120326 for AQT90 FLEX CKMB TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LEVELS 1-3, AQT90 FLEX CKMB CAL CARTRIDGE, Substantially Equivalent on 2012-11-21. 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
- Bronshoj, DK
Recent devices under product code JHX
view all- K234005 — Access CK-MB
- K212648 — VITROS Immunodiagnostic Products CK-MB Reagent Pack
- K163462 — AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX
- 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.