Roche Diagnostic Systems, Inc. · Class II · Cleared Mar 11, 1994
| K-number | K936130 |
| Device name | COBAS-FP REAGENT FOR PHENOBARBITAL AND COBAS-FP PHENOBARBITAL CALIBRATORS |
| Applicant | Roche Diagnostic Systems, Inc. |
| Product code | LGQ |
| Device class | Class II |
| Decision date | Mar 11, 1994 |
| Decision | Substantially Equivalent |
| Regulation | 862.3660 |
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