Clearance Summary
GAMMA-B 1,25-DIHYDROXY VITAMIN D received FDA 510(k) clearance under submission number K042519, sponsored by Immunodiagnostic Systems , Ltd.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2004-12-01.
- Submission: K042519
- Applicant / Sponsor: Immunodiagnostic Systems , Ltd.
- Clearance pathway: Abbreviated
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1825
- Decision date: 2004-12-01
Classification & Regulation
This clearance is catalogued under FDA product code MRG and 21 CFR 862.1825, within the Clinical Chemistry review panel as a Class II device.