Device Classification Name |
Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
|
510(k) Number |
K160495 |
Device Name |
VITROS® Automation Solutions |
Applicant |
Ortho-Clinical Diagnostics, Inc. |
100 Indigo Creek Drive MC00881 |
Rochester,
NY
14626
|
|
Applicant Contact |
Darlene J Phillips |
Correspondent |
Ortho-Clinical Diagnostics, Inc. |
100 Indigo Creek Drive MC00881 |
Rochester,
NY
14626
|
|
Correspondent Contact |
Darlene J Phillips |
Regulation Number | 862.1700
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 02/22/2016 |
Decision Date | 10/18/2016 |
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
|
Recalls |
CDRH Recalls
|
|
|