BGM GALECTIN -3— 510(k) K093758
Substantially EquivalentBg Medicine, Inc.
FDA 510(k) clearance K093758 for BGM GALECTIN -3, Substantially Equivalent on 2010-11-17. Applicant: Bg Medicine, Inc.. Device class: 2.
Clearance details
- Applicant
- Bg Medicine, Inc.
- Product code
- Code OSX
- Device class
- Class 2
- Regulation
- 21 CFR 862.1117
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Waltham, MA, US
Recent devices under product code OSX
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