Clearance Summary
VARELISA TPO ANTIBODIES, MODEL 12348/12396 received FDA 510(k) clearance under submission number K993585, 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 2000-01-05.
- Submission: K993585
- Applicant / Sponsor: Pharmacia & Upjohn Co.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5870
- Decision date: 2000-01-05
Classification & Regulation
This clearance is catalogued under FDA product code JZO and 21 CFR 866.5870, within the Immunology review panel as a Class II device.