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 |