Haemachem, Inc. · Class II · Cleared Feb 14, 1991
| K-number | K903874 |
| Device name | FIBRINOTEST(TM) - FIBRINOGEN ASSAY |
| Applicant | Haemachem, Inc. |
| Product code | GIS |
| Device class | Class II |
| Decision date | Feb 14, 1991 |
| Decision | Substantially Equivalent |
| Regulation | 864.7340 |
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