Clearance Summary
DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT FOR COBAS INTEGRA AND HOMOCYSTEINE CALIBRATOR received FDA 510(k) clearance under submission number K061296, sponsored by Diazyme Laboratories. The device was reviewed via the Special premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2006-06-13.
- Submission: K061296
- Applicant / Sponsor: Diazyme Laboratories
- Clearance pathway: Special
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1377
- Decision date: 2006-06-13
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.