Clearance Summary
ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT GALECTIN-3 CONTROLS received FDA 510(k) clearance under submission number K140436, sponsored by Fujirebio Diagnostics,Inc.. 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 2014-12-23.
- Submission: K140436
- Applicant / Sponsor: Fujirebio Diagnostics,Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1117
- Decision date: 2014-12-23
Classification & Regulation
This clearance is catalogued under FDA product code OSX and 21 CFR 862.1117, within the Clinical Chemistry review panel as a Class II device.