Clearance Summary
WIENER LAB.FOSFATEMIA UV, MODELS 1X100 ML CAT.N 1382321, 4X20 ML CAT.N 1009311 received FDA 510(k) clearance under submission number K013095, 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 2001-11-16.
- Submission: K013095
- Applicant / Sponsor: Wiener Laboratories Saic
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1580
- Decision date: 2001-11-16
Classification & Regulation
This clearance is catalogued under FDA product code CEO and 21 CFR 862.1580, within the Clinical Chemistry review panel as a Class I device.