Clearance Summary
RADIOIMMUNOASSAY, FOLLICLE STIMULATING received FDA 510(k) clearance under submission number K811993, 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 1981-08-03.
- Submission: K811993
- Applicant / Sponsor: Endocrine-Metabolic Center
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1300
- Decision date: 1981-08-03
Classification & Regulation
This clearance is catalogued under FDA product code CGJ and 21 CFR 862.1300, within the Clinical Chemistry review panel as a Class I device.