Device Classification Name |
test, time, prothrombin
|
510(k) Number |
K940082 |
Device Name |
THROMBOSCREEN THROMBOPLASTIN-DS |
Applicant |
PACIFIC HEMOSTASIS |
11515 VANSTORY DR. |
STE. 125 |
HUNTERSVILLE,
NC
28078
|
|
Applicant Contact |
JAMES MAYNARD, PH.D |
Correspondent |
PACIFIC HEMOSTASIS |
11515 VANSTORY DR. |
STE. 125 |
HUNTERSVILLE,
NC
28078
|
|
Correspondent Contact |
JAMES MAYNARD, PH.D |
Regulation Number | 864.7750
|
Classification Product Code |
|
Date Received | 01/07/1994 |
Decision Date | 02/14/1995 |
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
|
|
|