Clearance Summary
NDS CORTISOL TEST KIT AND NDS CORTISOL CALIBRATOR received FDA 510(k) clearance under submission number K900010, sponsored by Kallestad Diag, A Div. of Erbamont, 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 1990-04-03.
- Submission: K900010
- Applicant / Sponsor: Kallestad Diag, A Div. of Erbamont, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1205
- Decision date: 1990-04-03
Classification & Regulation
This clearance is catalogued under FDA product code JFT and 21 CFR 862.1205, within the Clinical Chemistry review panel as a Class II device.