The following data is part of a premarket notification filed by Pacific Hemostasis with the FDA for Prothrombin Reference Plasma (human).
| Device ID | K791022 |
| 510k Number | K791022 |
| Device Name: | PROTHROMBIN REFERENCE PLASMA (HUMAN) |
| Classification | Test, Time, Prothrombin |
| Applicant | PACIFIC HEMOSTASIS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GJS |
| CFR Regulation Number | 864.7750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-05-30 |
| Decision Date | 1979-07-24 |