Clearance Summary
NEPHROLYTE received FDA 510(k) clearance under submission number K831502, sponsored by Flaitron Laboratories, 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 1983-07-18.
- Submission: K831502
- Applicant / Sponsor: Flaitron Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.1850
- Decision date: 1983-07-18
Classification & Regulation
This clearance is catalogued under FDA product code KFC and 21 CFR 864.1850, within the Hematology review panel as a Class I device.