Clearance Summary
STANBIO LABORATORY SIRRUS CLINICAL CHEMISTRY ANALYZER received FDA 510(k) clearance under submission number K042169, sponsored by Stanbio Laboratory. 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 2005-03-14.
- Submission: K042169
- Applicant / Sponsor: Stanbio Laboratory
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2160
- Decision date: 2005-03-14
Classification & Regulation
This clearance is catalogued under FDA product code JJE and 21 CFR 862.2160, within the Clinical Chemistry review panel as a Class I device.