Clearance Summary
ANTI RNA POLYMERASE III ELISA KIT, MODEL 7805 received FDA 510(k) clearance under submission number K060431, sponsored by Mbl International Corporation. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2006-06-19.
- Submission: K060431
- Applicant / Sponsor: Mbl International Corporation
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5100
- Decision date: 2006-06-19
Classification & Regulation
This clearance is catalogued under FDA product code NYO and 21 CFR 866.5100, within the Immunology review panel as a Class II device.