Clearance Summary
COATED APEX PROBE received FDA 510(k) clearance under submission number K890735, sponsored by Analytic Technology. The device was reviewed via the Traditional premarket notification pathway and assigned to the Unknown review panel. The statutory decision date of record is 1989-04-19.
- Submission: K890735
- Applicant / Sponsor: Analytic Technology
- Clearance pathway: Traditional
- Review panel: Unknown
- Device class:
- Decision date: 1989-04-19
Classification & Regulation
This clearance is catalogued under FDA product code LQY , within the Unknown review panel as a device.