Clearance Summary
VARELISA RNP ANTIBODIES received FDA 510(k) clearance under submission number K993589, sponsored by Pharmacia & Upjohn Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 1999-11-26.
- Submission: K993589
- Applicant / Sponsor: Pharmacia & Upjohn Co.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5100
- Decision date: 1999-11-26
Classification & Regulation
This clearance is catalogued under FDA product code LKO and 21 CFR 866.5100, within the Immunology review panel as a Class II device.