Clearance Summary
APO B RIA KIT received FDA 510(k) clearance under submission number K851389, sponsored by Iso-Tex Diagnostics. 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 1985-07-10.
- Submission: K851389
- Applicant / Sponsor: Iso-Tex Diagnostics
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1475
- Decision date: 1985-07-10
Classification & Regulation
This clearance is catalogued under FDA product code MSJ and 21 CFR 862.1475, within the Clinical Chemistry review panel as a Class I device.