Device Classification Name |
Plasma, Coagulation Factor Deficient
|
510(k) Number |
K924396 |
Device Name |
CLOTTING FACTOR-VIII-IX-XI-XII 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 | 05/21/1993 |
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
|
|
|