Roche Diagnostics · Class II · Cleared Jun 18, 2009
| K-number | K090939 |
| Device name | ROCHE C.F.A.S. DAT QUALITATIVE PLUS CLINICAL CALIBRATOR AND CONTROL SET DAT CLINICAL, MODELS 04590856 190, 04500873 190 |
| Applicant | Roche Diagnostics |
| Product code | DKB |
| Device class | Class II |
| Decision date | Jun 18, 2009 |
| Decision | Substantially Equivalent |
| Regulation | 862.3200 |
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