Clearance Summary
CALBIOCHEM-BEHRING RIA-COUNT received FDA 510(k) clearance under submission number K792460, sponsored by Calbiochem-Behring Corp.. 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 1980-02-13.
- Submission: K792460
- Applicant / Sponsor: Calbiochem-Behring Corp.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1810
- Decision date: 1980-02-13
Classification & Regulation
This clearance is catalogued under FDA product code CDD and 21 CFR 862.1810, within the Clinical Chemistry review panel as a Class II device.