Clearance Summary
DELTA TROL I & II received FDA 510(k) clearance under submission number K853373, 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 1985-08-23.
- Submission: K853373
- Applicant / Sponsor: Electro-Nucleonics Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1660
- Decision date: 1985-08-23
Classification & Regulation
This clearance is catalogued under FDA product code JJT and 21 CFR 862.1660, within the Clinical Chemistry review panel as a Class I device.