Clearance Summary
WIENER LAB. STANDATROL S-E 2 NIVELES, LOVELS 1&2: 3X5 ML VIALS CAT.NR.1937553 received FDA 510(k) clearance under submission number K030482, sponsored by Wiener Laboratories. 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 2003-03-19.
- Submission: K030482
- Applicant / Sponsor: Wiener Laboratories
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1660
- Decision date: 2003-03-19
Classification & Regulation
This clearance is catalogued under FDA product code JJY and 21 CFR 862.1660, within the Clinical Chemistry review panel as a Class I device.