Device Classification Name |
Urease, Photometric, Urea Nitrogen
|
510(k) Number |
K001885 |
Device Name |
VITROS CHEMISTRY PRODUCTS BUN/UREA SLIDES AND VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1 |
Applicant |
Ortho-Clinical Diagnostics, Inc. |
100 INDIGO CREEK DR. |
ROCHESTER,
NY
14626 -5101
|
|
Applicant Contact |
MARLENE SHULMAN |
Correspondent |
Ortho-Clinical Diagnostics, Inc. |
100 INDIGO CREEK DR. |
ROCHESTER,
NY
14626 -5101
|
|
Correspondent Contact |
MARLENE SHULMAN |
Regulation Number | 862.1770
|
Classification Product Code |
|
Date Received | 06/21/2000 |
Decision Date | 07/20/2000 |
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
|
|
|