Clearance Summary
GOULD XCALIBER received FDA 510(k) clearance under submission number K862344, sponsored by Bio-Tek Instruments, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1986-08-06.
- Submission: K862344
- Applicant / Sponsor: Bio-Tek Instruments, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2850
- Decision date: 1986-08-06
Classification & Regulation
This clearance is catalogued under FDA product code DRS and 21 CFR 870.2850, within the Cardiovascular review panel as a Class II device.