Panels › Clinical Chemistry › Product code OSX · Class 2
Galectin-3 In Vitro Diagnostic Assay
Regulation 862.1117
0510(k)s in 12 months (2 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in OSX
| Company | 510(k)s | Recalls |
|---|---|---|
| Bg Medicine, Inc. | 1 | 0 |
| Fujirebio Diagnostics,Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 23, 2014 | K140436 | ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT GALECTIN-3 CONTROLS Fujirebio Diagnostics,Inc. | OSX |
| Nov 17, 2010 | K093758 | BGM GALECTIN -3 Bg Medicine, Inc. | OSX |
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