OSX — Galectin-3 In Vitro Diagnostic Assay Class II
FDA product code OSX covers "Galectin-3 In Vitro Diagnostic Assay", a Class II medical device regulated under 21 CFR 862.1117. Submissions are reviewed by the Clinical Chemistry panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OSX
- Device Class
- Class II
- Regulation Number
- 862.1117
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Definition
Galectin-3 is indicated for use in conjunction with clinical evaluation as an aid in assessing the prognosis of patients diagnosed with chronic heart failure.