Clearance Summary
RHIGENE MESACUP-2 ANTI-MITOCHONDRIA M2 TEST, MODEL 10760 received FDA 510(k) clearance under submission number K031308, 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 2003-09-26.
- Submission: K031308
- Applicant / Sponsor: Rhigene, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5090
- Decision date: 2003-09-26
Classification & Regulation
This clearance is catalogued under FDA product code DBM and 21 CFR 866.5090, within the Immunology review panel as a Class II device.