Clearance Summary
RADIOIMMUNOASSAY PARATHYROID HORMONE MID received FDA 510(k) clearance under submission number K821131, 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 1982-06-02.
- Submission: K821131
- Applicant / Sponsor: Endocrine-Metabolic Center
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1545
- Decision date: 1982-06-02
Classification & Regulation
This clearance is catalogued under FDA product code CEW and 21 CFR 862.1545, within the Clinical Chemistry review panel as a Class II device.