Clearance Summary
PHASE II B-12/FOLATE KIT received FDA 510(k) clearance under submission number K853224, sponsored by Medical & Scientific Designs, Inc.. 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 1985-10-03.
- Submission: K853224
- Applicant / Sponsor: Medical & Scientific Designs, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1810
- Decision date: 1985-10-03
Classification & Regulation
This clearance is catalogued under FDA product code CDD and 21 CFR 862.1810, within the Clinical Chemistry review panel as a Class II device.