The following data is part of a premarket notification filed by Pacific Hemostasis with the FDA for Thromboplastin.
| Device ID | K810350 |
| 510k Number | K810350 |
| Device Name: | THROMBOPLASTIN |
| Classification | Test, Time, Prothrombin |
| Applicant | PACIFIC HEMOSTASIS 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GJS |
| CFR Regulation Number | 864.7750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-02-10 |
| Decision Date | 1981-04-14 |