Roche Diagnostic Systems, Inc. · Class II · Cleared Jun 25, 1985
| K-number | K852319 |
| Device name | COBAS FP REAGENTS FOR NAPA AND NAPA CALIBRATORS |
| Applicant | Roche Diagnostic Systems, Inc. |
| Product code | LAN |
| Device class | Class II |
| Decision date | Jun 25, 1985 |
| Decision | Substantially Equivalent |
| Regulation | 862.3320 |
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