Clearance Summary
SPIFE LD VIS ISOENZYME KIT, MODELS 3450, 3451, AND 3452 received FDA 510(k) clearance under submission number K020467, sponsored by Helena Laboratories. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2002-03-29.
- Submission: K020467
- Applicant / Sponsor: Helena Laboratories
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1445
- Decision date: 2002-03-29
Classification & Regulation
This clearance is catalogued under FDA product code CFE and 21 CFR 862.1445, within the Clinical Chemistry review panel as a Class II device.