Clearance Summary
ANA-SCREEN WITH MDSS received FDA 510(k) clearance under submission number K113610, sponsored by Bio-Rad Laboratories. The device was reviewed via the Special premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2012-07-09.
- Submission: K113610
- Applicant / Sponsor: Bio-Rad Laboratories
- Clearance pathway: Special
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5100
- Decision date: 2012-07-09
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.