Clearance Summary
ESTRIOL RIA KIT FOR USE WITH GAMMAFLO received FDA 510(k) clearance under submission number K801424, sponsored by Squibb & Sons, 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 1980-07-21.
- Submission: K801424
- Applicant / Sponsor: Squibb & Sons, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1265
- Decision date: 1980-07-21
Classification & Regulation
This clearance is catalogued under FDA product code CGI and 21 CFR 862.1265, within the Clinical Chemistry review panel as a Class I device.