Clearance Summary
EKTACHEM DT LDL CHOLESTEROL KIT received FDA 510(k) clearance under submission number K955904, 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 1996-05-24.
- Submission: K955904
- Applicant / Sponsor: Johnson & Johnson Clinical Diagnostics, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1475
- Decision date: 1996-05-24
Classification & Regulation
This clearance is catalogued under FDA product code MRR and 21 CFR 862.1475, within the Clinical Chemistry review panel as a Class I device.