Device Classification Name |
Nadh Oxidation/Nad Reduction, Ast/Sgot
|
510(k) Number |
K001679 |
Device Name |
VITROS CHEMISTRY PRODUCTS AST SLIDE AND CHEMISTRY PRODUCTS CALIBRATOR KIT 3 |
Applicant |
Ortho-Clinical Diagnostics, Inc. |
100 INDIGO CREEK DR. |
ROCHESTER,
NY
14626 -5101
|
|
Applicant Contact |
MARLENE A SHULMAN |
Correspondent |
Ortho-Clinical Diagnostics, Inc. |
100 INDIGO CREEK DR. |
ROCHESTER,
NY
14626 -5101
|
|
Correspondent Contact |
MARLENE A SHULMAN |
Regulation Number | 862.1100
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 06/01/2000 |
Decision Date | 06/28/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|