Device Classification Name |
Calibrator, Multi-Analyte Mixture
|
510(k) Number |
K161140 |
Device Name |
VITROS Chemistry Products Calibrator Kit 3 |
Applicant |
ORTHO-CLINICAL DIAGNOSTICS, INC. |
100 INDIGO CREEK DRIVE |
ROCHESTER,
NY
14626 -5101
|
|
Applicant Contact |
MARLENE HANNA |
Correspondent |
ORTHO-CLINICAL DIAGNOSTICS, INC. |
100 INDIGO CREEK DRIVE |
ROCHESTER,
NY
14626 -5101
|
|
Correspondent Contact |
MARLENE HANNA |
Regulation Number | 862.1150
|
Classification Product Code |
|
Date Received | 04/22/2016 |
Decision Date | 05/20/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|