Clearance Summary
URINARY 17-KETOSTERIOD/17 received FDA 510(k) clearance under submission number K772337, sponsored by Eppendorf-Brinkmann, 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 1978-01-12.
- Submission: K772337
- Applicant / Sponsor: Eppendorf-Brinkmann, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1385
- Decision date: 1978-01-12
Classification & Regulation
This clearance is catalogued under FDA product code CDG and 21 CFR 862.1385, within the Clinical Chemistry review panel as a Class I device.