Device Classification Name |
Plasminogen, Antigen, Antiserum, Control
|
510(k) Number |
K884766 |
Device Name |
BERICHROM(R) PLASMINOGEN |
Applicant |
BEHRING DIAGNOSTICS, INC. |
17 CHUBB WAY |
SOMERVILLE,
NJ
08876
|
|
Applicant Contact |
JOHN E HUGHES |
Correspondent |
BEHRING DIAGNOSTICS, INC. |
17 CHUBB WAY |
SOMERVILLE,
NJ
08876
|
|
Correspondent Contact |
JOHN E HUGHES |
Regulation Number | 866.5715 |
Classification Product Code |
|
Date Received | 11/14/1988 |
Decision Date | 01/04/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Immunology
|
510k Review Panel |
Immunology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|