Clearance Summary
DUPONT ACA FIBRIN OGEN DEGRAD-PRODUCTS CALIBRATOR received FDA 510(k) clearance under submission number K852176, sponsored by E.I. Dupont DE Nemours & Co., Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1985-08-12.
- Submission: K852176
- Applicant / Sponsor: E.I. Dupont DE Nemours & Co., Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7320
- Decision date: 1985-08-12
Classification & Regulation
This clearance is catalogued under FDA product code GHH and 21 CFR 864.7320, within the Hematology review panel as a Class II device.