Clearance Summary
VMA BY HPLC TEST (VANILMANDELIC ACID) received FDA 510(k) clearance under submission number K861010, 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 1986-05-01.
- Submission: K861010
- Applicant / Sponsor: Bio-Rad
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1795
- Decision date: 1986-05-01
Classification & Regulation
This clearance is catalogued under FDA product code CDF and 21 CFR 862.1795, within the Clinical Chemistry review panel as a Class I device.