Olympus Life & Material Science Europa GmbH (Irish · Class II · Cleared Jun 11, 2007
| K-number | K070453 |
| Device name | OLYMPUS D-DIMER REAGENT, MODEL OSR6X135, OLYMPUS D-DIMER CALIBRATOR, MODEL ODR3033, OLYMPUS D-DIMER CONTROL |
| Applicant | Olympus Life & Material Science Europa GmbH (Irish |
| Product code | GHH |
| Device class | Class II |
| Decision date | Jun 11, 2007 |
| Decision | Substantially Equivalent |
| Regulation | 864.7320 |
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