Clearance Summary
GI MONITOR AND GI MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387687, 387688 received FDA 510(k) clearance under submission number K033038, sponsored by Beckman Coulter, 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 2003-12-29.
- Submission: K033038
- Applicant / Sponsor: Beckman Coulter, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.6010
- Decision date: 2003-12-29
Classification & Regulation
This clearance is catalogued under FDA product code NIG and 21 CFR 866.6010, within the Immunology review panel as a Class II device.