Clearance Summary
CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KIT received FDA 510(k) clearance under submission number K062503, sponsored by Catachem, 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 2007-01-19.
- Submission: K062503
- Applicant / Sponsor: Catachem, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1177
- Decision date: 2007-01-19
Classification & Regulation
This clearance is catalogued under FDA product code KWW and 21 CFR 862.1177, within the Clinical Chemistry review panel as a Class II device.