Clearance Summary
FastPack High Sensitivity C-Reactive Protein Immunoassay, High Sensitivity C-Reactive Protein Calibrator Kit, FastPack High Sensitivity C-Reactive Protein Controls, FastPack High Sensitivity C-Reactive Protein Method Verification Kit received FDA 510(k) clearance under submission number K141689, sponsored by Qualigen, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2015-01-07.
- Submission: K141689
- Applicant / Sponsor: Qualigen, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5270
- Decision date: 2015-01-07
Classification & Regulation
This clearance is catalogued under FDA product code DCK and 21 CFR 866.5270, within the Immunology review panel as a Class II device.