Clearance Summary
RHIGENE DSG-1 & DSG-3 ELISA TEST SYSTEM, MODEL 7680 E received FDA 510(k) clearance under submission number K000336, sponsored by Rhigene, 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 2000-06-09.
- Submission: K000336
- Applicant / Sponsor: Rhigene, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5660
- Decision date: 2000-06-09
Classification & Regulation
This clearance is catalogued under FDA product code NBO and 21 CFR 866.5660, within the Immunology review panel as a Class II device.