Device Classification Name |
Enzyme Immunoassay, Phenobarbital
|
510(k) Number |
K984288 |
Device Name |
VITROS CHEMISTRY PRODUCTS PHBR SLIDES |
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 | 862.3660
|
Classification Product Code |
|
Date Received | 12/01/1998 |
Decision Date | 01/26/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Toxicology
|
510k Review Panel |
Toxicology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|