Clearance Summary
ACA PROTHROMBIN TIME ANALYTICAL TEST PACK received FDA 510(k) clearance under submission number K851125, 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 1985-05-29.
- Submission: K851125
- Applicant / Sponsor: E.I. Dupont DE Nemours & Co., Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7750
- Decision date: 1985-05-29
Classification & Regulation
This clearance is catalogued under FDA product code GJS and 21 CFR 864.7750, within the Hematology review panel as a Class II device.