Clearance Summary
SPIFE URINE IFE received FDA 510(k) clearance under submission number K982639, sponsored by Helena Laboratories. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 1998-11-04.
- Submission: K982639
- Applicant / Sponsor: Helena Laboratories
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5550
- Decision date: 1998-11-04
Classification & Regulation
This clearance is catalogued under FDA product code DAO and 21 CFR 866.5550, within the Immunology review panel as a Class II device.