Clearance Summary
ATS MAYER'S ALBUMIN received FDA 510(k) clearance under submission number K890022, sponsored by Alpha-Tec Systems, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Pathology review panel. The statutory decision date of record is 1989-01-10.
- Submission: K890022
- Applicant / Sponsor: Alpha-Tec Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Pathology
- Device class: Class I
- Regulation citation: 21 CFR 864.4010
- Decision date: 1989-01-10
Classification & Regulation
This clearance is catalogued under FDA product code KEL and 21 CFR 864.4010, within the Pathology review panel as a Class I device.