Clearance Summary
NICHOLS ADVANTAGE HYPERGLYCOSYLATED HUMAN CHORIONIC GONADOTROPIN (H-HCG) ASSAY received FDA 510(k) clearance under submission number K042676, sponsored by Nichols Institute Diagnostics. 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 2004-12-17.
- Submission: K042676
- Applicant / Sponsor: Nichols Institute Diagnostics
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1155
- Decision date: 2004-12-17
Classification & Regulation
This clearance is catalogued under FDA product code DHA and 21 CFR 862.1155, within the Clinical Chemistry review panel as a Class II device.