Clearance Summary
ANALYTIC TECHNOLOGY ENDO ANALYZER MODEL 8001 received FDA 510(k) clearance under submission number K864500, 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 1987-03-19.
- Submission: K864500
- Applicant / Sponsor: Analytic Technology
- Clearance pathway: Traditional
- Review panel: Unknown
- Device class:
- Decision date: 1987-03-19
Classification & Regulation
This clearance is catalogued under FDA product code LQY , within the Unknown review panel as a device.