Siemens Healthcare Diagnostics, Inc. · Class I · Cleared Oct 22, 2013
| K-number | K133128 |
| Device name | IMMULITE 2000; HCG CALIBRATION VERIFICATION MATERIAL, INSULIN CALIBRATION VERIFICATION MATERIAL, PYRILINKS-D CALIBRATION |
| Applicant | Siemens Healthcare Diagnostics, Inc. |
| Product code | JJX |
| Device class | Class I |
| Decision date | Oct 22, 2013 |
| Decision | Substantially Equivalent |
| Regulation | 862.1660 |
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