Clearance Summary
DELTATEST (R) LIPASE II received FDA 510(k) clearance under submission number K893718, sponsored by Electro-Nucleonics, 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 1989-09-28.
- Submission: K893718
- Applicant / Sponsor: Electro-Nucleonics, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1465
- Decision date: 1989-09-28
Classification & Regulation
This clearance is catalogued under FDA product code CET and 21 CFR 862.1465, within the Clinical Chemistry review panel as a Class I device.