Clearance Summary
DETECTADOT SYSTEM 2000 HETEROPHILE TEST received FDA 510(k) clearance under submission number K895891, sponsored by Gull 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 1989-10-31.
- Submission: K895891
- Applicant / Sponsor: Gull Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5640
- Decision date: 1989-10-31
Classification & Regulation
This clearance is catalogued under FDA product code KTN and 21 CFR 866.5640, within the Immunology review panel as a Class II device.