Clearance Summary
GEMENI AST-LTS REAGENTS received FDA 510(k) clearance under submission number K851267, sponsored by Electro-Nucleonics Laboratories, 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 1985-04-29.
- Submission: K851267
- Applicant / Sponsor: Electro-Nucleonics Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1100
- Decision date: 1985-04-29
Classification & Regulation
This clearance is catalogued under FDA product code CIT and 21 CFR 862.1100, within the Clinical Chemistry review panel as a Class II device.