Clearance Summary
WIENER LAB.FER-COLOR AA, MODEL 5X 20 ML CAT.N 1492003 received FDA 510(k) clearance under submission number K013097, 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 2001-11-13.
- Submission: K013097
- Applicant / Sponsor: Wiener Laboratories Saic
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1410
- Decision date: 2001-11-13
Classification & Regulation
This clearance is catalogued under FDA product code JIY and 21 CFR 862.1410, within the Clinical Chemistry review panel as a Class I device.