Clearance Summary
WIENER LAB. BILIRUBINA DIRECT AA received FDA 510(k) clearance under submission number K024116, sponsored by Wiener Laboratories Saic. 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 2003-02-12.
- Submission: K024116
- Applicant / Sponsor: Wiener Laboratories Saic
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1110
- Decision date: 2003-02-12
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.