Clearance Summary
AUTOMATED ANALYSIS ASSAY FOR BILIRUBIN IN URINE received FDA 510(k) clearance under submission number K951877, sponsored by Chimera Research & Chemical, 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 1996-05-14.
- Submission: K951877
- Applicant / Sponsor: Chimera Research & Chemical, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2900
- Decision date: 1996-05-14
Classification & Regulation
This clearance is catalogued under FDA product code KQO and 21 CFR 862.2900, within the Clinical Chemistry review panel as a Class I device.