The following data is part of a premarket notification filed by General Diagnostics with the FDA for Coag-a-mate X2.
| Device ID | K813564 |
| 510k Number | K813564 |
| Device Name: | COAG-A-MATE X2 |
| Classification | Instrument, Coagulation, Automated |
| Applicant | GENERAL DIAGNOSTICS 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GKP |
| CFR Regulation Number | 864.5400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-12-22 |
| Decision Date | 1982-01-28 |