Serono-Baker Diagnostics, Inc. · Class II · Cleared Aug 16, 1991
| K-number | K911217 |
| Device name | SR1 T4 ENZYME IMMUNOASSAY (MAGNETIC SOLID-PHASE) |
| Applicant | Serono-Baker Diagnostics, Inc. |
| Product code | KLI |
| Device class | Class II |
| Decision date | Aug 16, 1991 |
| Decision | Substantially Equivalent |
| Regulation | 862.1700 |
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