Clearance Summary
DRABKIN REAGENT received FDA 510(k) clearance under submission number K842931, sponsored by E K Ind., Inc.. 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 1984-09-21.
- Submission: K842931
- Applicant / Sponsor: E K Ind., Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.1800
- Decision date: 1984-09-21
Classification & Regulation
This clearance is catalogued under FDA product code KAG and 21 CFR 878.1800, within the General, Plastic Surgery review panel as a Class I device.