Beckman Coulter, Inc. · Class II · Cleared Dec 14, 1998
| K-number | K983340 |
| Device name | IMMAGE IMMUNOCHEMISTRY SYSTEM FERRITIN (FER)REAGENT, IMMAGE IMMUNOCHEMISTRY SYSTEM FERRITIN CALIBRATOR |
| Applicant | Beckman Coulter, Inc. |
| Product code | DBF |
| Device class | Class II |
| Decision date | Dec 14, 1998 |
| Decision | Substantially Equivalent |
| Regulation | 866.5340 |
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