Clearance Summary
ACA (R) DIGITOXIN CALIBRATOR received FDA 510(k) clearance under submission number K891093, sponsored by E.I. Dupont DE Nemours & Co., 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 1989-04-26.
- Submission: K891093
- Applicant / Sponsor: E.I. Dupont DE Nemours & Co., Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class I
- Regulation citation: 21 CFR 866.5160
- Decision date: 1989-04-26
Classification & Regulation
This clearance is catalogued under FDA product code DCJ and 21 CFR 866.5160, within the Immunology review panel as a Class I device.