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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 5, 2017 | CSL Behring GmbH SIEMENS N/T Protein Control SL for use on the BN II, BN ProSpec Systems: N/T Protein Control SL/L: REF/Product Code OQIN19, SMN 10446079 (Low); N/T Protein Control SL/M, REF/Product Code OQIO19, SMN 1 Terminated |
CHN | K052788 |
| Jun 5, 2017 | CSL Behring GmbH SIEMENS N Protein Standard SL, for use on the BN II, BN ProSpec Systems, REF/Product Code OQIM 13, Siemens Material Number (SMN)10446073 Terminated |
CHN | K012470 |
| May 23, 2017 | Siemens Healthcare Diagnostics, Inc. Dimension Vista Protein 1 Control H, PROT 1 CON H, Siemens Material Number (SMN) 10445921, Product Code KC717; IVD. Terminated |
CHN | None listed |
| May 23, 2017 | Siemens Healthcare Diagnostics, Inc. Dimension Vista Protein 1 Control M, PROT 1 CON M, Siemens Material Number (SMN) 10445920, Product Code KC716; IVD Terminated |
CHN | K083463 |
| May 23, 2017 | Siemens Healthcare Diagnostics, Inc. Dimension Vista Protein 1 Control, PROT 1 CON L, Siemens Material Number (SMN) 10445919, Product Code KC715; IVD Terminated |
CHN | K083463 |
| May 23, 2017 | Siemens Healthcare Diagnostics, Inc. Dimension Vista Protein 1 Calibrator, PROT 1 CAL, Siemens Material Number (SMN) 10465664 (US) and 10469516 (OUS), Product Code KC710U (US) and KC710 (OUS); IVD Terminated |
CHN | K082503 |
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