Phadia US, Inc. · Class II · Cleared May 28, 2009
| K-number | K083117 |
| Device name | ELIA RNP70 IMMUNOASSAY, ELIA SCI-70 IMMUNOASSAY AND ELIA JO-1 IMMUNOASSAY, MODELS 14-5511-01, 14-5506-01 AND 14-5507-01 |
| Applicant | Phadia US, Inc. |
| Product code | LKO |
| Device class | Class II |
| Decision date | May 28, 2009 |
| Decision | Substantially Equivalent |
| Regulation | 866.5100 |
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