Device Classification Name |
ldl & vldl precipitation, cholesterol via esterase-oxidase, hdl
|
510(k) Number |
K162593 |
Device Name |
HDL-Cholesterol Gen.4 |
Applicant |
Roche Diagnostics Operations (RDO) |
9115 Hague Road |
Indianapolis,
IN
46250
|
|
Applicant Contact |
Barbara McWhorter |
Correspondent |
Roche Diagnostics Operations (RDO) |
9115 Hague Road |
SUITE 114 |
Indianapolis,
IN
46250
|
|
Correspondent Contact |
Barbara McWhorter |
Regulation Number | 862.1475
|
Classification Product Code |
|
Date Received | 09/16/2016 |
Decision Date | 10/19/2016 |
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
|
|
|