510(k) K093758
K093758 is an FDA 510(k) premarket notification submitted by Bg Medicine, Inc. for the device "BGM GALECTIN -3". The FDA issued a decision of Substantially Equivalent on November 17, 2010. The device falls under product code OSX (Galectin-3 In Vitro Diagnostic Assay), a Class II device regulated under 21 CFR 862.1117.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 17, 2010
- Date Received
- December 7, 2009
- 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.