Device Classification Name |
Method, Nephelometric, Immunoglobulins (G, A, M)
|
510(k) Number |
K130122 |
Device Name |
BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN, BECKMAN COULTER |
Applicant |
BECKMAN COULTER, INC |
250 S. KRAEMER BLVD |
E1.SE. 01 |
BREA,
CA
92821
|
|
Applicant Contact |
AMANDA BROWN |
Correspondent |
BECKMAN COULTER, INC |
250 S. KRAEMER BLVD |
E1.SE. 01 |
BREA,
CA
92821
|
|
Correspondent Contact |
AMANDA BROWN |
Regulation Number | 866.5510
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/17/2013 |
Decision Date | 01/07/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Immunology
|
510k Review Panel |
Immunology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|