Panels › Immunology › Product code OIU · Class 2
Test, Epithelial Ovarian Tumor Associated Antigen (He4)
Regulation 866.6010
0510(k)s in 12 months (5 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in OIU
| Company | 510(k)s | Recalls |
|---|---|---|
| Fujirebio Diagnostics,Inc. | 4 | 0 |
| Roche Diagnostics | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 24, 2015 | K151378 | Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 Calibrators Fujirebio Diagnostics,Inc. | OIU |
| Sep 10, 2012 | K112624 | ELECSYS HE4, ELECSYS HE4 CALSET, ELECSYS PRECICONTROL HE4, ELECSYS HE4 CALCHECK 5 Roche Diagnostics | OIU |
| Jul 19, 2011 | K103676 | FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL Fujirebio Diagnostics,Inc. | OIU |
| Mar 18, 2010 | K093957 | ARCHITECT HE4, ARCHITECT HE4 CALIBRATORS AND ARCHITECT HE4 CONTROLS, MODELS 2, 2P54, 2P54-01, 2P54-10 SP54-01, Fujirebio Diagnostics,Inc. | OIU |
| Jun 9, 2008 | K072939 | HE4 EIA, MODEL: 404-10 US Fujirebio Diagnostics,Inc. | OIU |
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