Roche Diagnostic Systems, Inc. · Class I · Cleared Oct 1, 1998
| K-number | K982848 |
| Device name | COBAS INTEGRA LDL DIRECT REAGENT CASSETTE ROCHE CALIBRATOR LDL DIRECT |
| Applicant | Roche Diagnostic Systems, Inc. |
| Product code | MRR |
| Device class | Class I |
| Decision date | Oct 1, 1998 |
| Decision | Substantially Equivalent |
| Regulation | 862.1475 |
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