Clearance Summary
IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-MICROGLOBULIN (AI) REAGENT received FDA 510(k) clearance under submission number K965033, sponsored by Beckman Instruments, 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 1997-04-21.
- Submission: K965033
- Applicant / Sponsor: Beckman Instruments, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class I
- Regulation citation: 21 CFR 866.5400
- Decision date: 1997-04-21
Classification & Regulation
This clearance is catalogued under FDA product code MGA and 21 CFR 866.5400, within the Immunology review panel as a Class I device.