Clearance Summary
ESTRONE ANALYSIS PRODUCTS RADIOIMMUNOASSAY ESTRONE received FDA 510(k) clearance under submission number K864966, sponsored by Diagnostics Biochem Canada, Inc.. 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 1987-01-09.
- Submission: K864966
- Applicant / Sponsor: Diagnostics Biochem Canada, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1280
- Decision date: 1987-01-09
Classification & Regulation
This clearance is catalogued under FDA product code CGF and 21 CFR 862.1280, within the Clinical Chemistry review panel as a Class I device.