Clearance Summary
AMER. BIO-SCIENCE LAB CORTISOL REAGENT received FDA 510(k) clearance under submission number K842455, sponsored by American Bio-Science Laboratories. 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 1984-08-16.
- Submission: K842455
- Applicant / Sponsor: American Bio-Science Laboratories
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1205
- Decision date: 1984-08-16
Classification & Regulation
This clearance is catalogued under FDA product code CGR and 21 CFR 862.1205, within the Clinical Chemistry review panel as a Class II device.