Device Classification Name |
radioimmunoassay, testosterones and dihydrotestosterone
|
510(k) Number |
K152155 |
Device Name |
ARCHITECT 2nd Generation Testosterone |
Applicant |
Abbott Laboratories |
100 Abbott Park Rd, Dept. 093G, Bldg. AP8-1 |
Abbott Park,
IL
60064
|
|
Applicant Contact |
Regina Xavier Kumar |
Correspondent |
Abbott Laboratories |
100 Abbott Park Rd, Dept. 093G, Bldg. AP8-1 |
Abbott Park,
IL
60064
|
|
Correspondent Contact |
Regina Xavier Kumar |
Regulation Number | 862.1680
|
Classification Product Code |
|
Date Received | 08/03/2015 |
Decision Date | 12/17/2015 |
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
|
|
|