Device Classification Name |
System, Test, Human Chorionic Gonadotropin
|
510(k) Number |
K130020 |
Device Name |
ACCESS TOTAL BHCG (5TH IS) |
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 | 862.1155
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/03/2013 |
Decision Date | 10/01/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|