Panels › Immunology › Product code CHN · Class 2
Immunochemical, Ceruloplasmin
Regulation 866.5210
0510(k)s in 12 months (3 all time)
0recalls in 12 months (6 all time)
5recalls that name a 510(k)
Top companies in CHN
| Company | 510(k)s | Recalls |
|---|---|---|
| Siemens Healthcare Diagnostics, Inc. | 0 | 4 |
| CSL Behring GmbH | 0 | 2 |
| Roche Diagnostics | 2 | 0 |
| Dade Behring, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 18, 2010 | K091741 | TINA-QUANT CERULOPLASMIN Roche Diagnostics | CHN |
| Feb 15, 2007 | K063655 | DIMENSION VISTA; CER FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, PROTEIN 1 CONTROL HIGH Dade Behring, Inc. | CHN |
| Jan 31, 2007 | K062114 | CERULOPLASMIN, MODEL 2055953 Roche Diagnostics Corp. | CHN |
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