Submission Details
| 510(k) Number | K881174 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 18, 1988 |
| Decision Date | June 08, 1988 |
| Days to Decision | 82 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |