| K-number | K881281 |
| Device name | COAG-A-MATE(R) XM |
| Applicant | Organon Teknika Corp. |
| Product code | GKP |
| Device class | Class II |
| Decision date | May 18, 1988 |
| Decision | Substantially Equivalent |
| Regulation | 864.5400 |
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