Clearance Summary
MESACUP MODELS BP180 AND BP230 ELISA KITS received FDA 510(k) clearance under submission number K071961, 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 2008-08-25.
- Submission: K071961
- Applicant / Sponsor: Mbl International Corporation
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5660
- Decision date: 2008-08-25
Classification & Regulation
This clearance is catalogued under FDA product code OEG and 21 CFR 866.5660, within the Immunology review panel as a Class II device.