Clearance Summary
CHIRON DIAGNOSTICS ACS:180 MYOGLOBIN received FDA 510(k) clearance under submission number K974325, 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 1997-12-08.
- Submission: K974325
- Applicant / Sponsor: Chiron Diagnostics Corp.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5680
- Decision date: 1997-12-08
Classification & Regulation
This clearance is catalogued under FDA product code DDR and 21 CFR 866.5680, within the Immunology review panel as a Class II device.