Clearance Summary
AMYLASE LTS received FDA 510(k) clearance under submission number K862640, 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 1986-09-09.
- Submission: K862640
- Applicant / Sponsor: Electro-Nucleonics Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1070
- Decision date: 1986-09-09
Classification & Regulation
This clearance is catalogued under FDA product code CJA and 21 CFR 862.1070, within the Clinical Chemistry review panel as a Class II device.