Clearance Summary
RIA, INSULIN, DOUBLE ANTIBODY received FDA 510(k) clearance under submission number K790630, sponsored by Endocrine-Metabolic Center. 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 1979-07-24.
- Submission: K790630
- Applicant / Sponsor: Endocrine-Metabolic Center
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1405
- Decision date: 1979-07-24
Classification & Regulation
This clearance is catalogued under FDA product code CFP and 21 CFR 862.1405, within the Clinical Chemistry review panel as a Class I device.