Roche Diagnostics Corp. · Class I · Cleared Sep 14, 2004
| K-number | K042389 |
| Device name | MODIFICATION TO PRECINORM UNIVERSAL PLUS AND PRECIPATH UNIVERSAL PLUS CONTROL SERA |
| Applicant | Roche Diagnostics Corp. |
| Product code | JJY |
| Device class | Class I |
| Decision date | Sep 14, 2004 |
| Decision | Substantially Equivalent |
| Regulation | 862.1660 |
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