OIU
ARCHITECT HE4, ARCHITECT HE4 CALIBRATORS AND ARCHITECT HE4 CONTROLS, MODELS 2, 2P54, 2P54-01, 2P54-10 SP54-01,
- Advisory panel
- Immunology
- Total cleared
- 5
Recent clearances under product code OIU
- K151378 — Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 Calibrators
- K112624 — ELECSYS HE4, ELECSYS HE4 CALSET, ELECSYS PRECICONTROL HE4, ELECSYS HE4 CALCHECK 5
- K103676 — FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL
- K093957 — ARCHITECT HE4, ARCHITECT HE4 CALIBRATORS AND ARCHITECT HE4 CONTROLS, MODELS 2, 2P54, 2P54-01, 2P54-10 SP54-01,
- K072939 — HE4 EIA, MODEL: 404-10 US
Data sourced from openFDA. This site is unofficial and independent of the FDA.