Roche Diagnostics Corp. · Class I · Cleared Nov 10, 2009
| K-number | K092888 |
| Device name | ELECSYS TOXO IGG CALCHECK 5 |
| Applicant | Roche Diagnostics Corp. |
| Product code | JJX |
| Device class | Class I |
| Decision date | Nov 10, 2009 |
| 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