Device Classification Name |
calibrator, secondary
|
510(k) Number |
K170160 |
Device Name |
Abbott ARCHITECT Free T3 |
Applicant |
Abbott Laboratories |
100 Abbott Park Road, Dept 09AA, Bldg. AP08 |
Abbott Park,
IL
60064
|
|
Applicant Contact |
Linda Sohn |
Correspondent |
Abbott Laboratories |
100 Abbott Park Road, Dept 09AA, Bldg. AP08 |
Abbott Park,
IL
60064
|
|
Correspondent Contact |
Linda Sohn |
Regulation Number | 862.1150
|
Classification Product Code |
|
Date Received | 01/18/2017 |
Decision Date | 02/15/2017 |
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
|
|
|