Device Classification Name |
immunochemical, thyroglobulin autoantibody
|
510(k) Number |
K112933 |
Device Name |
ACCESS THYROGLOBULIN ANITBODY |
Applicant |
BECKMAN COULTER, INC. |
1000 LAKE HAZELTINE DR. |
CHASKA,
MN
55318 -1084
|
|
Applicant Contact |
GERALDINE L BAGLIEN |
Correspondent |
BECKMAN COULTER, INC. |
1000 LAKE HAZELTINE DR. |
CHASKA,
MN
55318 -1084
|
|
Correspondent Contact |
GERALDINE L BAGLIEN |
Regulation Number | 866.5870
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/03/2011 |
Decision Date | 12/27/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Immunology
|
510k Review Panel |
Immunology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|