Clearance Summary
SERA-TEK MICROSOMAL ANTIBODY TEST received FDA 510(k) clearance under submission number K865053, sponsored by Miles Laboratories, 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 1987-02-18.
- Submission: K865053
- Applicant / Sponsor: Miles Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5870
- Decision date: 1987-02-18
Classification & Regulation
This clearance is catalogued under FDA product code JZO and 21 CFR 866.5870, within the Immunology review panel as a Class II device.