Olympus America, Inc. · Class II · Cleared Mar 18, 2009
| K-number | K081615 |
| Device name | OLYMPUS CEA - CARCINOEMBRYONIC ANTIGEN |
| Applicant | Olympus America, Inc. |
| Product code | DHX |
| Device class | Class II |
| Decision date | Mar 18, 2009 |
| Decision | Substantially Equivalent |
| Regulation | 866.6010 |
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