Device Classification Name |
c-reactive protein, antigen, antiserum, and control
|
510(k) Number |
K953197 |
Device Name |
EKTACHEM CLINICAL CHEMISTRY SLIDE C-REACTIVE PROTEIN (CRP) |
Applicant |
JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. |
100 INDIGO CREEK DR. |
ROCHESTER,
NY
14650 -0882
|
|
Applicant Contact |
YVONNE E MIDDLEFELL |
Correspondent |
JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. |
100 INDIGO CREEK DR. |
ROCHESTER,
NY
14650 -0882
|
|
Correspondent Contact |
YVONNE E MIDDLEFELL |
Regulation Number | 866.5270
|
Classification Product Code |
|
Date Received | 07/10/1995 |
Decision Date | 07/31/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Immunology
|
510k Review Panel |
Immunology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|