Columbia Bioscience, Inc. · Class I · Cleared Nov 25, 1998
| K-number | K982348 |
| Device name | EBNA-1 IGM ELISA TEST SYSTEM |
| Applicant | Columbia Bioscience, Inc. |
| Product code | LSE |
| Device class | Class I |
| Decision date | Nov 25, 1998 |
| Decision | Substantially Equivalent |
| Regulation | 866.3235 |
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