Device Classification Name |
multi-analyte controls, all kinds (assayed)
|
510(k) Number |
K983507 |
Device Name |
VITROS IMMUNODIAGNOSTIC PRODUCTS TESTOSTERONE ASSAY |
Applicant |
Ortho-Clinical Diagnostics, Inc. |
100 INDIGO CREEK DR. |
ROCHESTER,
NY
14626 -5101
|
|
Applicant Contact |
ANNE ZAVERTNIK |
Correspondent |
Ortho-Clinical Diagnostics, Inc. |
100 INDIGO CREEK DR. |
ROCHESTER,
NY
14626 -5101
|
|
Correspondent Contact |
ANNE ZAVERTNIK |
Regulation Number | 862.1660
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 10/07/1998 |
Decision Date | 11/04/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|