Ortho-Clinical Diagnostics, Inc. · Class II · Cleared Jun 30, 2008
| K-number | K081411 |
| Device name | VITROS CHEMISTRY PRODUCT NA+ SLIDES; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2 |
| Applicant | Ortho-Clinical Diagnostics, Inc. |
| Product code | JGS |
| Device class | Class II |
| Decision date | Jun 30, 2008 |
| Decision | Substantially Equivalent |
| Regulation | 862.1665 |
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