Clearance Summary
CHOLESTECH LDX ALANINE AMINOTRANSFERASE (ALT), MODEL 11-772 received FDA 510(k) clearance under submission number K991834, sponsored by Cholestech Corp.. 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 1999-09-09.
- Submission: K991834
- Applicant / Sponsor: Cholestech Corp.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1030
- Decision date: 1999-09-09
Classification & Regulation
This clearance is catalogued under FDA product code CKD and 21 CFR 862.1030, within the Clinical Chemistry review panel as a Class I device.