Device Classification Name |
plasma, coagulation factor deficient
|
510(k) Number |
K924394 |
Device Name |
CLOTTING FACTOR V DEFICIENT PLASMA |
Applicant |
BEHRING DIAGNOSTICS, INC. |
17 CHUBB WAY |
SOMERVILLE,
NJ
08876
|
|
Applicant Contact |
JOSEPH KICEINA |
Correspondent |
BEHRING DIAGNOSTICS, INC. |
17 CHUBB WAY |
SOMERVILLE,
NJ
08876
|
|
Correspondent Contact |
JOSEPH KICEINA |
Regulation Number | 864.7290
|
Classification Product Code |
|
Date Received | 08/31/1992 |
Decision Date | 12/01/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|