Clearance Summary
RANDOX PREALBUMIN received FDA 510(k) clearance under submission number K000661, sponsored by Randox Laboratories, Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2000-04-13.
- Submission: K000661
- Applicant / Sponsor: Randox Laboratories, Ltd.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class I
- Regulation citation: 21 CFR 866.5060
- Decision date: 2000-04-13
Classification & Regulation
This clearance is catalogued under FDA product code JZJ and 21 CFR 866.5060, within the Immunology review panel as a Class I device.