Siemens Healthcare Diagnostics, Inc. · Class I · Cleared Apr 1, 2014
| K-number | K140541 |
| Device name | IMMULITE 2000: C-PEPTIDE CALIBRATION VERIFICATION MATERIAL, SHBG CALIBRATION VERIFICATION MATERIAL, TOTAL TESTOSTERONE C |
| Applicant | Siemens Healthcare Diagnostics, Inc. |
| Product code | JJX |
| Device class | Class I |
| Decision date | Apr 1, 2014 |
| Decision | Substantially Equivalent |
| Regulation | 862.1660 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov