Panels › Immunology › Product code JHR · Class 2
Radioimmunoassay, Immunoglobulins (D, E)
Regulation 866.5510
0510(k)s in 12 months (9 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in JHR
| Company | 510(k)s | Recalls |
|---|---|---|
| Diagnostic Products Corp. | 3 | 0 |
| Pharmacia, Inc. | 2 | 0 |
| Siemens Healthcare Diagnostics | 0 | 2 |
| Boehringer Mannheim Corp. | 1 | 0 |
| Roche Diagnostics | 1 | 0 |
| Techniclone Intl. | 1 | 0 |
| Ventrex Laboratories, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 25, 2014 | Siemens Healthcare Diagnostics IMMULITE 2000 /IMMULITE 2000 XPi Systems TIE Total IgE, REF L2KIE2, SMN 10380873, and L2KIE6, SMN 10380872, IVD --- Siemens Healthcare Diagnostics Products Ltd.
For in vitro diagnostic use with the I Terminated |
JHR | K931703 |
| Apr 25, 2014 | Siemens Healthcare Diagnostics IMMULITE /IMMULITE 1000 Systems TIE Total IgE, REF LKIE1, SMN 10380867, IVD --- Siemens Healthcare Diagnostics Products Ltd. For in vitro diagnostic use with the IMMULITE, IMMULITE 1000, and IMMULITE Terminated |
JHR | K931703 K960067 |
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