Sigma Diagnostics, Inc. · Class II · Cleared Oct 20, 1997
| K-number | K972260 |
| Device name | CS-400 COAGULATION ANALYZER SYSTEM (A1208) |
| Applicant | Sigma Diagnostics, Inc. |
| Product code | JPA |
| Device class | Class II |
| Decision date | Oct 20, 1997 |
| Decision | Substantially Equivalent |
| Regulation | 864.5425 |
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