Clearance Summary
BECKMAN DIRECT BILIRUBIN REAGENT received FDA 510(k) clearance under submission number K934068, sponsored by Beckman-Diagnostic Systems Group. 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 1994-04-26.
- Submission: K934068
- Applicant / Sponsor: Beckman-Diagnostic Systems Group
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1110
- Decision date: 1994-04-26
Classification & Regulation
This clearance is catalogued under FDA product code CIG and 21 CFR 862.1110, within the Clinical Chemistry review panel as a Class II device.