The following data is part of a premarket notification filed by Pacific Hemostasis with the FDA for Thromboscreen.
| Device ID | K820450 |
| 510k Number | K820450 |
| Device Name: | THROMBOSCREEN |
| Classification | Reagent & Control, Partial Thromboplastin Time |
| Applicant | PACIFIC HEMOSTASIS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GIT |
| CFR Regulation Number | 864.7925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-02-18 |
| Decision Date | 1982-03-26 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() THROMBOSCREEN 72188391 0787698 Dead/Expired |
CHAS. PFIZER & CO., INC. 1964-03-10 |