Clearance Summary
GEN PROFILER SYSTEM received FDA 510(k) clearance under submission number K851619, sponsored by Electro-Cucleonics, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 1985-05-14.
- Submission: K851619
- Applicant / Sponsor: Electro-Cucleonics, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2140
- Decision date: 1985-05-14
Classification & Regulation
This clearance is catalogued under FDA product code JJG and 21 CFR 862.2140, within the Clinical Chemistry review panel as a Class I device.