Clearance Summary
ACS:180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM FOR THE QUANTITATION OF CANCER ANTIGEN 27.29) received FDA 510(k) clearance under submission number K970695, sponsored by Chiron Diagnostics Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 1997-08-08.
- Submission: K970695
- Applicant / Sponsor: Chiron Diagnostics Corp.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.6010
- Decision date: 1997-08-08
Classification & Regulation
This clearance is catalogued under FDA product code MOI and 21 CFR 866.6010, within the Immunology review panel as a Class II device.