Clearance Summary
ANTISERA TO HUMAN FAB FRAGMENT received FDA 510(k) clearance under submission number K771243, sponsored by Kent Laboratories, 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 1977-08-03.
- Submission: K771243
- Applicant / Sponsor: Kent Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class I
- Regulation citation: 21 CFR 866.5520
- Decision date: 1977-08-03
Classification & Regulation
This clearance is catalogued under FDA product code DFK and 21 CFR 866.5520, within the Immunology review panel as a Class I device.