Clearance Summary
ARCHITECT HE4, ARCHITECT HE4 CALIBRATORS AND ARCHITECT HE4 CONTROLS, MODELS 2, 2P54, 2P54-01, 2P54-10 SP54-01, received FDA 510(k) clearance under submission number K093957, sponsored by Fujirebio Diagnostics,Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2010-03-18.
- Submission: K093957
- Applicant / Sponsor: Fujirebio Diagnostics,Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.6010
- Decision date: 2010-03-18
Classification & Regulation
This clearance is catalogued under FDA product code OIU and 21 CFR 866.6010, within the Immunology review panel as a Class II device.