Device Classification Name |
system, fibrinogen determination
|
510(k) Number |
K800826 |
Device Name |
FIBRINOGEN SCREEN |
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 | 864.7340
|
Classification Product Code |
|
Date Received | 04/14/1980 |
Decision Date | 05/30/1980 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|