Clearance Summary
SODIUM CHLORIDE SOLUTION BLOOD CELL received FDA 510(k) clearance under submission number K841183, sponsored by Reagent Laboratory, 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 1984-05-21.
- Submission: K841183
- Applicant / Sponsor: Reagent Laboratory, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4370
- Decision date: 1984-05-21
Classification & Regulation
This clearance is catalogued under FDA product code FNW and 21 CFR 878.4370, within the General, Plastic Surgery review panel as a Class II device.