Clearance Summary
AUTO I.D. JO-1, SCL-70 & PCNA POSITIVE CONTROL SERUM received FDA 510(k) clearance under submission number K030775, sponsored by Immuno Concepts, N.A. , Ltd.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2003-05-12.
- Submission: K030775
- Applicant / Sponsor: Immuno Concepts, N.A. , Ltd.
- Clearance pathway: Abbreviated
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5100
- Decision date: 2003-05-12
Classification & Regulation
This clearance is catalogued under FDA product code LKJ and 21 CFR 866.5100, within the Immunology review panel as a Class II device.