Device Classification Name |
Immunoassay Method, Troponin Subunit
|
510(k) Number |
K191595 |
Device Name |
ARCHITECT STAT High Sensitivity Troponin-I |
Applicant |
Abbott Laboratories Diagnostics Division |
Dept. 09AA, Bldg. AP8, 100 Abbott Park Road |
Abbott Park,
IL
60064 -6038
|
|
Applicant Contact |
Judi Wallach |
Correspondent |
Abbott Laboratories Diagnostics Division |
Dept. 09AA, Bldg, AP8, 100 Abbott Park Road |
Abbott Park,
IL
60064 -6038
|
|
Correspondent Contact |
Judi Wallach |
Regulation Number | 862.1215
|
Classification Product Code |
|
Date Received | 06/17/2019 |
Decision Date | 09/13/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Clinical Trials |
NCT01608100
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|