Clearance Summary
CAT 15-HEMATOLOGY & PATHOLOGY DEVICE received FDA 510(k) clearance under submission number K840319, sponsored by Imm Enterprises , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1984-03-12.
- Submission: K840319
- Applicant / Sponsor: Imm Enterprises , Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 1984-03-12
Classification & Regulation
This clearance is catalogued under FDA product code HTD and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.