Clearance Summary
AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON received FDA 510(k) clearance under submission number K112790, sponsored by Axis-Shield Diagnostics, Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2012-05-07.
- Submission: K112790
- Applicant / Sponsor: Axis-Shield Diagnostics, Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1377
- Decision date: 2012-05-07
Classification & Regulation
This clearance is catalogued under FDA product code LPS and 21 CFR 862.1377, within the Clinical Chemistry review panel as a Class II device.