Clearance Summary
ALLO-TYPE HUMAN IMMUNOGLOBULIN- received FDA 510(k) clearance under submission number K841114, sponsored by Genetic Testing Institute. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 1984-06-14.
- Submission: K841114
- Applicant / Sponsor: Genetic Testing Institute
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class I
- Regulation citation: 21 CFR 866.5065
- Decision date: 1984-06-14
Classification & Regulation
This clearance is catalogued under FDA product code DGX and 21 CFR 866.5065, within the Immunology review panel as a Class I device.