Clearance Summary
VENTANA EMA PRIMARY ANDIBODY received FDA 510(k) clearance under submission number K940243, sponsored by Ventana Medical Systems, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 1994-09-07.
- Submission: K940243
- Applicant / Sponsor: Ventana Medical Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class I
- Regulation citation: 21 CFR 866.5065
- Decision date: 1994-09-07
Classification & Regulation
This clearance is catalogued under FDA product code DHF and 21 CFR 866.5065, within the Immunology review panel as a Class I device.