The following data is part of a premarket notification filed by General Diagnostics with the FDA for Coag-a-mate 2001.
| Device ID | K790323 |
| 510k Number | K790323 |
| Device Name: | COAG-A-MATE 2001 |
| Classification | System, Multipurpose For In Vitro Coagulation Studies |
| Applicant | GENERAL DIAGNOSTICS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JPA |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-02-15 |
| Decision Date | 1979-03-21 |