Clearance Summary
CELLTRAK-B received FDA 510(k) clearance under submission number K834585, sponsored by R&D Systems, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1984-05-02.
- Submission: K834585
- Applicant / Sponsor: R&D Systems, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6775
- Decision date: 1984-05-02
Classification & Regulation
This clearance is catalogued under FDA product code FRZ and 21 CFR 880.6775, within the General Hospital review panel as a Class II device.