Clearance Summary
URINARY VMA - SCREEN TEST KIT received FDA 510(k) clearance under submission number K772151, sponsored by Eppendorf-Brinkmann, 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 1977-11-30.
- Submission: K772151
- Applicant / Sponsor: Eppendorf-Brinkmann, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1795
- Decision date: 1977-11-30
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.