COAG-A-MATE X2
Device Facts
| Record ID | K813564 |
|---|---|
| Device Name | COAG-A-MATE X2 |
| Applicant | General Diagnostics |
| Product Code | GKP · Hematology |
| Decision Date | Jan 28, 1982 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.5400 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A coagulation instrument is an automated or semiautomated device used to determine the onset of clot formation for in vitro coagulation studies.
Special Controls
*Classification.* Class II (special controls). A fibrometer or coagulation timer intended for use with a coagulation instrument is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
