Heraeus Kulzer, Inc. · Class II · Cleared Mar 8, 1989
| K-number | K884528 |
| Device name | SERALYZER DIGOXIN ASSAY/TEST MOD/CALIB/CONTR/AMES |
| Applicant | Heraeus Kulzer, Inc. |
| Product code | KXT |
| Device class | Class II |
| Decision date | Mar 8, 1989 |
| Decision | Substantially Equivalent |
| Regulation | 862.3320 |
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