Clearance Summary
AUTOTECHNICON V TISSUE PROCESS SYS received FDA 510(k) clearance under submission number K834599, sponsored by Technicon Instruments Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Pathology review panel. The statutory decision date of record is 1984-02-04.
- Submission: K834599
- Applicant / Sponsor: Technicon Instruments Corp.
- Clearance pathway: Traditional
- Review panel: Pathology
- Device class: Class I
- Regulation citation: 21 CFR 864.3875
- Decision date: 1984-02-04
Classification & Regulation
This clearance is catalogued under FDA product code IEO and 21 CFR 864.3875, within the Pathology review panel as a Class I device.