Clearance Summary
REAADS DSDNA QUANTITATIVE TEST KIT, MODEL 022-001 received FDA 510(k) clearance under submission number K034013, sponsored by Corgenix, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2004-01-08.
- Submission: K034013
- Applicant / Sponsor: Corgenix, Inc.
- Clearance pathway: Special
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5100
- Decision date: 2004-01-08
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.