Clearance Summary
ELECTRO IMMUNO ASSAY KIT received FDA 510(k) clearance under submission number K770150, sponsored by Millipore Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 1977-02-01.
- Submission: K770150
- Applicant / Sponsor: Millipore Corp.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class I
- Regulation citation: 21 CFR 866.4500
- Decision date: 1977-02-01
Classification & Regulation
This clearance is catalogued under FDA product code JZS and 21 CFR 866.4500, within the Immunology review panel as a Class I device.