Clearance Summary
BIO-RAD URINARY 5-HIAA BY HPLC received FDA 510(k) clearance under submission number K952817, sponsored by Bio-Rad. 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 1995-08-01.
- Submission: K952817
- Applicant / Sponsor: Bio-Rad
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1390
- Decision date: 1995-08-01
Classification & Regulation
This clearance is catalogued under FDA product code CDA and 21 CFR 862.1390, within the Clinical Chemistry review panel as a Class I device.