Device Classification Name |
radioimmunoassay, testosterones and dihydrotestosterone
|
510(k) Number |
K120009 |
Device Name |
TESTOSTERONE TEST SYSTEM; CALIBRATOR; AND QUALITY CONTROL MATERIAL (ASSAYED AND UNASSAYED) |
Applicant |
ABBOTT LABORATORIES |
100 ABBOTT PARK ROAD |
DEPT 9V6, AP5N-2 |
ABBOTT PARK,
IL
60064
|
|
Applicant Contact |
JOHN RIZOS |
Correspondent |
ABBOTT LABORATORIES |
100 ABBOTT PARK ROAD |
DEPT 9V6, AP5N-2 |
ABBOTT PARK,
IL
60064
|
|
Correspondent Contact |
JOHN RIZOS |
Regulation Number | 862.1680
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 01/03/2012 |
Decision Date | 09/11/2012 |
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
|
|
|