Device Classification Name |
Immunoassay Method, Troponin Subunit
|
510(k) Number |
K162895 |
Device Name |
Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet, Elecsys PreciControl Troponin, Elecsys Troponin T Gen 5 CalCheck 5 |
Applicant |
Roche Diagnostics |
9115 Hague Road |
Indianapolis,
IN
46250
|
|
Applicant Contact |
Jane Phillips |
Correspondent |
Roche Diagnostics |
9115 Hague Road |
Indianapolis,
IN
46250
|
|
Correspondent Contact |
Jane E Phillips |
Regulation Number | 862.1215
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 10/17/2016 |
Decision Date | 01/18/2017 |
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
|
|
|