Sorin Biomedica, Fiat, USA, Inc. · Class I · Cleared Jan 11, 1984
| K-number | K832694 |
| Device name | DIRIA-PROGK IMMUNOASSAY |
| Applicant | Sorin Biomedica, Fiat, USA, Inc. |
| Product code | JLS |
| Device class | Class I |
| Decision date | Jan 11, 1984 |
| Decision | Substantially Equivalent |
| Regulation | 862.1620 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov