Clearance Summary
URINARY FREE CATECHOLAMINES & METANEPHRINES (HPLC) received FDA 510(k) clearance under submission number K873371, 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 1988-01-05.
- Submission: K873371
- Applicant / Sponsor: Bio-Rad
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1165
- Decision date: 1988-01-05
Classification & Regulation
This clearance is catalogued under FDA product code CHQ and 21 CFR 862.1165, within the Clinical Chemistry review panel as a Class I device.