Clearance Summary
URIN. L7-OH CORTICOSTEROID T(NON HYDRO) received FDA 510(k) clearance under submission number K761271, 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 1977-02-14.
- Submission: K761271
- Applicant / Sponsor: Eppendorf-Brinkmann, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1385
- Decision date: 1977-02-14
Classification & Regulation
This clearance is catalogued under FDA product code CDB and 21 CFR 862.1385, within the Clinical Chemistry review panel as a Class I device.