Clearance Summary
IRMA IMMUNORADIOMETRIC ASSAY-FSH 125I received FDA 510(k) clearance under submission number K843930, sponsored by Euro-Diagnostics BV. 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 1984-10-30.
- Submission: K843930
- Applicant / Sponsor: Euro-Diagnostics BV
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1300
- Decision date: 1984-10-30
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.