Clearance Summary
EKTACHEM CLINICAL CHEMISTRY SLIDE C-REACTIVE PROTEIN (CRP) received FDA 510(k) clearance under submission number K953197, sponsored by Johnson & Johnson Clinical Diagnostics, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 1995-07-31.
- Submission: K953197
- Applicant / Sponsor: Johnson & Johnson Clinical Diagnostics, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5270
- Decision date: 1995-07-31
Classification & Regulation
This clearance is catalogued under FDA product code DCK and 21 CFR 866.5270, within the Immunology review panel as a Class II device.