ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT GALECTIN-3 CONTROLS
FDA 510(k) clearance K140436 · decided 2014-12-23
Clearance details
- K-number
- K140436
- Device name
- ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT GALECTIN-3 CONTROLS
- Applicant
- Fujirebio Diagnostics,Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-02-21
- Decision date
- 2014-12-23
- Days to decision
- 305 days
- Clearance type
- Traditional
- Product code
- OSX
- Device class
- 2
- Regulation number
- 862.1117
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Malvern, PA, 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 |
|---|---|---|
| BGM GALECTIN -3 (K093758) | Bg Medicine, Inc. | 2010-11-17 |
Recalls involving this device
No recalls on record reference this clearance.