Clearance Summary
GEMSTAR SYSTEM received FDA 510(k) clearance under submission number K821335, 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 1982-07-13.
- Submission: K821335
- Applicant / Sponsor: Electro-Nucleonics Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2160
- Decision date: 1982-07-13
Classification & Regulation
This clearance is catalogued under FDA product code JJE and 21 CFR 862.2160, within the Clinical Chemistry review panel as a Class I device.