510(k) K140436
K140436 is an FDA 510(k) premarket notification submitted by Fujirebio Diagnostics,Inc. for the device "ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT GALECTIN-3 CONTROLS". The FDA issued a decision of Substantially Equivalent on December 23, 2014. The device falls under product code OSX (Galectin-3 In Vitro Diagnostic Assay), a Class II device regulated under 21 CFR 862.1117. Fujirebio Diagnostics,Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 23, 2014
- Date Received
- February 21, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Galectin-3 In Vitro Diagnostic Assay
- Device Class
- Class II
- Regulation Number
- 862.1117
- Review Panel
- CH
- Submission Type
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.