Clearance Summary
DAKOCYTOMATION BETA-2-MICROGLOBULIN KIT, CODE NO. OA 368 received FDA 510(k) clearance under submission number K032692, sponsored by Dako A/S. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2004-01-22.
- Submission: K032692
- Applicant / Sponsor: Dako A/S
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5630
- Decision date: 2004-01-22
Classification & Regulation
This clearance is catalogued under FDA product code JZG and 21 CFR 866.5630, within the Immunology review panel as a Class II device.