Clearance Summary
QUANTITOPE 125I-FOLATE RADIOASSAY KIT received FDA 510(k) clearance under submission number K780508, sponsored by Kallestad Laboratories, 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 1978-05-03.
- Submission: K780508
- Applicant / Sponsor: Kallestad Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1295
- Decision date: 1978-05-03
Classification & Regulation
This clearance is catalogued under FDA product code CGN and 21 CFR 862.1295, within the Clinical Chemistry review panel as a Class II device.