Clearance Summary
ELSA-PTH received FDA 510(k) clearance under submission number K950211, 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 1995-04-13.
- Submission: K950211
- Applicant / Sponsor: Cis-Us, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1545
- Decision date: 1995-04-13
Classification & Regulation
This clearance is catalogued under FDA product code CEW and 21 CFR 862.1545, within the Clinical Chemistry review panel as a Class II device.