Clearance Summary
APOLIPOPROTEIN A-I (APO A-I) received FDA 510(k) clearance under submission number K901675, sponsored by Sigma Chemical Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 1990-04-26.
- Submission: K901675
- Applicant / Sponsor: Sigma Chemical Co.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class I
- Regulation citation: 21 CFR 866.5590
- Decision date: 1990-04-26
Classification & Regulation
This clearance is catalogued under FDA product code DEL and 21 CFR 866.5590, within the Immunology review panel as a Class I device.