Serono Diagnostics, Inc. · Class II · Cleared Jul 31, 1987
| K-number | K872897 |
| Device name | TSH SEROZYME IMMUNOENZYMETRIC KIT, MAG. SOLID PHA. |
| Applicant | Serono Diagnostics, Inc. |
| Product code | JLW |
| Device class | Class II |
| Decision date | Jul 31, 1987 |
| Decision | Substantially Equivalent |
| Regulation | 862.1690 |
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