Clearance Summary
NDS THYROXINE TEST KIT & NDS THYROXINE CALIBRATOR received FDA 510(k) clearance under submission number K897072, 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 1990-03-29.
- Submission: K897072
- Applicant / Sponsor: Kallestad Diag, A Div. of Erbamont, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1700
- Decision date: 1990-03-29
Classification & Regulation
This clearance is catalogued under FDA product code KLI and 21 CFR 862.1700, within the Clinical Chemistry review panel as a Class II device.