Clearance Summary
GEMENI GPT (ALT) ASSAY received FDA 510(k) clearance under submission number K761269, 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 1976-12-29.
- Submission: K761269
- Applicant / Sponsor: Electro-Nucleonics Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1030
- Decision date: 1976-12-29
Classification & Regulation
This clearance is catalogued under FDA product code CKA and 21 CFR 862.1030, within the Clinical Chemistry review panel as a Class I device.