Clearance Summary
IRON/TOTAL IRON BINDING CAPACITY received FDA 510(k) clearance under submission number K901561, sponsored by Tech-Co, 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 1990-05-17.
- Submission: K901561
- Applicant / Sponsor: Tech-Co, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1410
- Decision date: 1990-05-17
Classification & Regulation
This clearance is catalogued under FDA product code JIY and 21 CFR 862.1410, within the Clinical Chemistry review panel as a Class I device.