Device Classification Name |
Test, Time, Prothrombin
|
510(k) Number |
K791022 |
Device Name |
PROTHROMBIN REFERENCE PLASMA (HUMAN) |
Applicant |
PACIFIC HEMOSTASIS |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
PACIFIC HEMOSTASIS |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 864.7750
|
Classification Product Code |
|
Date Received | 05/30/1979 |
Decision Date | 07/24/1979 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|