Clearance Summary
NICHOLS ADVANTAGE DIRECT RENIN (CALIBRATORS, CALIBRATION VERIFIERS, CONTROLS, AND SAMPLE DILUENT) received FDA 510(k) clearance under submission number K011128, sponsored by Nichols Institute Diagnostics. 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 2001-09-06.
- Submission: K011128
- Applicant / Sponsor: Nichols Institute Diagnostics
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1085
- Decision date: 2001-09-06
Classification & Regulation
This clearance is catalogued under FDA product code CIB and 21 CFR 862.1085, within the Clinical Chemistry review panel as a Class II device.