| K-number | K920216 |
| Device name | SYN ELISA MICRO ALBUMIN |
| Applicant | Elias U.S.A., Inc. |
| Product code | JIR |
| Device class | Class I |
| Decision date | Mar 11, 1992 |
| Decision | Substantially Equivalent |
| Regulation | 862.1645 |
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