Clearance Summary
ACA FIBRINOGEN CALIBRATOR received FDA 510(k) clearance under submission number K812628, 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 1981-11-24.
- Submission: K812628
- Applicant / Sponsor: E.I. Dupont DE Nemours & Co., Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7340
- Decision date: 1981-11-24
Classification & Regulation
This clearance is catalogued under FDA product code GFX and 21 CFR 864.7340, within the Hematology review panel as a Class II device.