Clearance Summary
EKTACHEM CLINICAL CHEMISTRY UREA NITROGEN/UREA (BUN/UREA) received FDA 510(k) clearance under submission number K961196, sponsored by Johnson & Johnson Clinical Diagnostics, 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 1996-05-15.
- Submission: K961196
- Applicant / Sponsor: Johnson & Johnson Clinical Diagnostics, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1770
- Decision date: 1996-05-15
Classification & Regulation
This clearance is catalogued under FDA product code CDN and 21 CFR 862.1770, within the Clinical Chemistry review panel as a Class II device.