Clearance Summary
25-HYDROXYVITAMIN D 125I RIA KIT received FDA 510(k) clearance under submission number K983617, sponsored by DiaSorin, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 1998-11-16.
- Submission: K983617
- Applicant / Sponsor: DiaSorin, Inc.
- Clearance pathway: Special
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2050
- Decision date: 1998-11-16
Classification & Regulation
This clearance is catalogued under FDA product code LCI and 21 CFR 862.2050, within the Clinical Chemistry review panel as a Class I device.