BGM GALECTIN -3
FDA 510(k) clearance K093758 · decided 2010-11-17
Clearance details
- K-number
- K093758
- Device name
- BGM GALECTIN -3
- Applicant
- Bg Medicine, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-12-07
- Decision date
- 2010-11-17
- Days to decision
- 345 days
- Clearance type
- Traditional
- Product code
- OSX
- Device class
- 2
- Regulation number
- 862.1117
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Waltham, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT GALECTIN-3 CONTROLS (K140436) | Fujirebio Diagnostics,Inc. | 2014-12-23 |
Recalls involving this device
No recalls on record reference this clearance.