Device Classification Name |
Enzyme Immunoassay, Carbamazepine
|
510(k) Number |
K980283 |
Device Name |
VITROS CHEMISTRY PRODUCTS CRBM SLIDES |
Applicant |
JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. |
100 INDIGO CREEK DR. |
ROCHESTER,
NY
14650 -0882
|
|
Applicant Contact |
CHARLES C MORGANSON |
Correspondent |
JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. |
100 INDIGO CREEK DR. |
ROCHESTER,
NY
14650 -0882
|
|
Correspondent Contact |
CHARLES C MORGANSON |
Regulation Number | 862.3645
|
Classification Product Code |
|
Date Received | 01/26/1998 |
Decision Date | 02/25/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Toxicology
|
510k Review Panel |
Clinical Chemistry
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|