Clearance Summary
ELSA-HCT received FDA 510(k) clearance under submission number K951708, sponsored by Cis-Us, 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 1995-09-05.
- Submission: K951708
- Applicant / Sponsor: Cis-Us, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1140
- Decision date: 1995-09-05
Classification & Regulation
This clearance is catalogued under FDA product code JKR and 21 CFR 862.1140, within the Clinical Chemistry review panel as a Class II device.