Clearance Summary
Allergen-Specific IgE Assay 12 Allergen Bundle received FDA 510(k) clearance under submission number K193613, sponsored by Hitachi Chemical 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 2021-10-18.
- Submission: K193613
- Applicant / Sponsor: Hitachi Chemical Diagnostics, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5750
- Decision date: 2021-10-18
Classification & Regulation
This clearance is catalogued under FDA product code DHB and 21 CFR 866.5750, within the Immunology review panel as a Class II device.