Clearance Summary
REAGENT, BUN (UREA NITROGEN) DETERM. received FDA 510(k) clearance under submission number K760478, sponsored by Simmler & Son, 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 1976-10-29.
- Submission: K760478
- Applicant / Sponsor: Simmler & Son, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1770
- Decision date: 1976-10-29
Classification & Regulation
This clearance is catalogued under FDA product code CDW and 21 CFR 862.1770, within the Clinical Chemistry review panel as a Class II device.