The following data is part of a premarket notification filed by Pacific Hemostasis with the FDA for Pacific Hemostasis Thrombo-screen Kaptt.
| Device ID | K801460 |
| 510k Number | K801460 |
| Device Name: | PACIFIC HEMOSTASIS THROMBO-SCREEN KAPTT |
| Classification | Test, Time, Partial Thromboplastin |
| Applicant | PACIFIC HEMOSTASIS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GGW |
| CFR Regulation Number | 864.7925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-06-24 |
| Decision Date | 1980-07-28 |